Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of April 5, 2021.

Number 5: Seeking to develop a biosimilar portfolio, Stada Arzneimittel has 

Number 4: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a 

 for a subcutaneous (SC) infliximab biosimilar candidate from Celltrion.

Number 3: India has tightened up guidelines for biosimilar development in a 

 standards equivalent to those in Europe and the United States.

Number 2: Shanghai Henlius Biotech began as a 2-person enterprise in 2010 and now has multiple oncology products in development and 3 biosimilars on the market. An executive discusses its 

Number 1: Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, 

 with a young clinician over the reliability of biosimilarity testing.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of April 5

 I'm Tony Hagen, senior editor for The Center for Biosimilars®. In a recent white paper, Richard G. Frank, PhD, of the Department of Health Care Policy at Harvard Medical School, and other authors wrote about the access problems faced by biosimilars in the United States market and how certain frictions are preventing these agents from getting to market. But they also found that as more biosimilars enter the marketplace, the prices for biologics are definitely coming down by significant increments. We spoke to Dr Richard G. Frank and Meaghan Rose Smith, the executive director of the Biosimilars Forum, which is a trade group for biosimilars manufacturers.

So, to start off with you, Dr Frank, you have written that originator biologics each have cumulative sales of $40 billion and been on the market for 17 years on average. What does this say about competition in the biologics sphere and the prices that Americans are paying for their medicine?

 Well, I think that because the regulatory structure of governing biologics is different than it is for small molecules, the way that we've promoted competition and the small molecule side doesn't translate directly. What I think has happened as a consequence is 2 things. There are legitimate reasons why the regulatory differences exist but what's happened is, (1) they've been a little bit sticky in terms of adapting to the biosimilar world, and (2) there has been industry behavior aimed at protecting exclusivity protections, both in terms of the regulatory context but also in the patent context that has gotten in the way of biosimilars being able to relatively frictionlessly enter the market.

CfB:Meaghan, do you have any thoughts there?

 Sure, I think that's all correct. Biosimilars are different than generics and there is a different regulatory structure, but the cost savings that they provide can be as important when you look at the increase in drug spending. That's all coming from the originator biologics, so making sure that we're able to access the cost savings from biosimilars is really going to be important. As Dr Frank's paper showed, when there's more competition, there's more savings. So, it's very critical that we find a way to increase that competition.

CfB:Dr Frank, can you explain some of the policy actions that are hindering biosimilar acceptance? You've referred to interchangeability, drug naming conventions, and CMS policy on separate codes and prices.

 Yeah, there's also patent policy that matters here. I think there's antitrust issues here that are potentially at play as well. I could just go down the list for you.

CfB:OK, do you want to hit some of the highlights you feel the strongest contenders should not be?

Well, the easier ones are, for example, changing the naming conventions. I think that would be helpful. We don't know exactly how helpful, but I think they would move the ball a step toward both doctors and patients not exaggerating differences between biosimilars and the originators. I think the development of a better process and a better understanding of how to get to interchangeability will be very important because that concept of interchangeability is what has really driven the success of the Hatch-Waxman Act in achieving the savings that (generics) have achieved. So, I think there is probably a lot more that could be done to advance the potential for interchangeability. Third, on the antitrust side, this is not a settled law yet, but I think we need to really understand bundled contracts and how they can be used to get in the way of entry and demand for biosimilars. Those would be my top 3 right now.

CfB:Okay. Meaghan, did you want to chime in there?

 Sure. Particularly on interchangeability, that's going to be more of an issue potentially in a few years in the [Medicare] Part D space. That's an area where I think misinformation has led to some confusion, where that's not necessary in Part B for physicians to be making the switch to a biosimilar. Physicians always have the freedom to prescribe whatever drug they believe is appropriate for their patients. But that difference has led to confusion and I think some have taken advantage of that. And I know the FDA and FTC have been working together to try and fight some of that misinformation and some of these anticompetitive practices that have really held back biosimilars getting to patients. And in terms of policies, in addition to what you've mentioned, the Forum has really pushed toward right sizing those incentives that we think are currently backwards and making sure that particularly when a physician feels that a switch may be necessary, they have the proper incentives or have no incentive holding them back from doing that.

 If you don't mind, I'd like to sort of tie this into…how you build confidence in physicians when they prescribe [biosimilars]. And while I think that Meaghan was completely right that interchangeability is going to be especially important on the Part D side. On the [Medicare] Part B side, it's important potentially because the data that I'm examining right now show that take-up is driven heavily by the arrival of new patients—this reluctance to switch. I think that if there was interchangeability designated, that would give a great deal of confidence to physicians that they could switch safely. For that reason, even though the primary benefit is this long-term Part D type of benefit, there would be a significant short-term impact because of that extra confidence.

CfB:Let me jump in there with a question on interchangeability. So far, we have no interchangeable biosimilars. Meaghan, have you heard much scuttlebutt in the Biosimilars Forum about the prospects for an application or a modified application for an interchangeable biosimilar in the near future?

 I would look at some of the markets outside the United States to watch closely what's happening there. So, number 1, I'm not aware of any potential interchangeable designation coming in the United States. That's point number 1. And then point number 2 is that [interchangeability] could also be another potential anticompetitive loophole or blockade from an originator brand that they put in front of other competitive products.

CfB:Do you mean that they come up with ways to demonstrate, perhaps in a courtroom setting, that a biosimilar does not qualify on a parallel scale with an originator product?

 I was talking more about if they were then to develop an interchangeable biosimilar of their own.

CfB:Dr Frank, in your study, you mentioned that with few market entrants, the price decreases that many have hoped for from biosimilars are really quite modest, maybe on the order of 5% increments. Can you explain that a little bit and perhaps give us your thoughts on which way you think this is going?

 Just to clarify, we presented a range of estimates: 5% of the low side and 10% of the high side. So, it's somewhere between 5% and 10% for every extra biosimilar comes in. We evaluated that, too. So, if you go from 2 to 3, you get somewhere between the 5% and 10% reduction price. If you go from 2 to 4, you get somewhere between 10% and 20%. I think those are modest by small molecule standards and generics. But, in a sense, you have a line of argument that also says that there's no hope here and that what you want is a public utility regulation model. I think what our results suggest is that it's probably premature to give up on the market. In fact, there are indications that from these early adventures, in a sense, that there are some meaningful reductions in prices, as you crank up competition.

CfB:Meaghan, do you have any thoughts on that? Are we seeing meaningful decreases from the biosimilar sector?

 "Early adventures" in Biosimilarland? I do think it's still an emerging market. When you compare it to where we were, in the generic landscape, 11 years after the Hatch-Waxman Act and we're at the 11th anniversary of the ACA [Affordable Care Act] and the BPCIA [Biologics Price Competition and Innovation Act], it's still a young, emerging market. Number 1, there's clear room to grow and [there are] things we need to do to enhance that growth. There should be more competition and there should be more market share for biosimilars. Patients should have more access. So, this is not where we want it to be, but there are signs that are in the [white] paper that competition is lowering prices, even for patients who are on the originator brand biologic therapy. More competition equals more price reductions. We don't want just 1 biosimilar competing against the reference biologic. We want lots of biosimilars out there competing and giving patients options and bringing down prices.

 Yeah, I think the historical point that Meaghan made is really important because if you think about the Hatch-Waxman Act, there were modest effects early on. But the really big ones that we think about, the ones that save trillions of dollars, really didn't start until the mid- to late-1990s. I think about 1997 to 1999 as being like banner years where you saw huge impacts. It's really at that point that things took off and we're not there yet in terms of biosimilars. And biosimilars, just science wise and regulatory wise, are just harder [to make]. And so, I think that, again, it's premature. The other thing that I think is very important, another point that Meaghan made was that unlike small molecules, what you see is pretty big input originator price responses to entry by biosimilars. Whereas, in fact, you saw the opposite generally in the small molecule space, which is where they raised the prices rather than lowered the prices.

CfB:We've heard recently that there's this concern that the originator companies anticipate the arrival of biosimilars by increasing their prices. So, years before a biosimilar actually steps into the market, an originator has begun increasing its price, sometimes by dramatic steps. AbbVie's Humira [adalimumab] is a strong example, with 7%, 8%, and 9% annual increases. This sets the bar higher. When a biosimilar steps in the market, it can offer a discount, but that discount has much more leeway to come in at a higher level than [the biosimilar company] may have anticipated before. Do you have thoughts on this phenomenon?

 Well, I'm not sure I buy the story entirely because if you look at lots and lots of drugs where there is no biosimilar threat at all, you see pretty significant price increases. In fact, that's one of the targets of public policy, is that the price increases are going up without any new information about efficacy or any big change in market conditions, including inflation, to justify them. So, I'm not sure I buy it even though I think the point you're making about creating more room for biosimilars to enter profitably is probably the case.

 I know there are a number of lower cost biosimilar products planned for entry to compete with Humira, and that's the number 1 selling biologic and there have been a number of games to delay entry of those biosimilar products. Along with what Richard was saying, I can't say if the reason for the price increases was because of planned biosimilar competition or for other reasons but I think it does point to the severe need for competition to lower those prices.

CfB:It'll be very interesting to see what happens in 2023. We have at least 6 adalimumab biosimilars coming onto the market. Whereas, up until now, we've seen biosimilars come in 1 at a time. So, what happens to the pricing levels at that point will be very, very interesting to see.

 Sure, and as we've talked about with the number of products and increased competition, that will be really interesting.

CfB:Contracts and rebate practices are identified as an issue in the report. Biosimilar companies also rely on these practices. Meaghan, could you comment on this aspect of marketing and the heavy reliance on these deals to acquire market share?

 Sure. So, I know this is something that the FDA has pointed out as a potential anticompetitive practice. The FDA and [Federal Trade Commission] have held a workshop on it as an issue. There are some anticompetitive practices that are blocking patient access to some lower cost products. Some of these practices we've talked about needing to fix like fail first [step therapy], which doesn't necessarily make sense. You have to fail first on the reference product before you can have the biosimilar and it's clear that, just from a patient perspective, it's not going to work. That's certainly something that we're taking a look at.

 I think the issue here is using a portfolio of rebates as leverage for exclusionary practices is a key thing. What Meaghan pointed to is an exclusionary practice, which is these fail first policies, which, in a sense, take the concept of fail first and stand it on its head. Typically, the reason we had fail first was to get people to adopt generics quicker, and only if they failed on the generic would they get to the brand drug. This does the opposite and serves essentially to exclude use of biosimilars. The economics are starting to be worked out on this. The antitrust law has not yet been sorted out on this, but I think that is coming. There are cases, including the one around Remicade [infliximab], where this is a fundamental issue. I think we're going to see some clarification on the antitrust law and the antitrust economics over the next couple of years as these things are sorted out.

CfB:Now, Remicade is an example of a reference product where you've seen the least decline in prices yet.

 Although, if you see the picture in our report, it's actually accelerated recently. What's interesting is that most of the decline in price has come because the originator dropped its price because they've held on to a very large share of the market. So, even at the end of that, they're still holding I think north of 90% of the market, which cushions their price declines a little bit because they do hang on to things and the prices are still at a pretty high level.

 Yes, and that's the case where the biosimilar has ended up benefiting patients due to decreasing the costs for patients overall. One of the biosimilars launched at a 35% lower price than Remicade and still the market share is quite low, as you pointed out.

CfB:What's to account for that lack of movement in the originator price, and the change in market share do you think, Meaghan.

 So, I think there are a couple issues that we talked about. One is some of the contracting practices that are an issue. There's also an issue with provider behavior for different disease states that Richard referred to where a lot of the biosimilar uptake is taken up by new patients. If you look at some of the differences between the oncology products and the oncology disease state, compared with some of the other reference products where providers and patients are managing a chronic condition, patients are on an oncology product for a shorter time. So, physicians are not battling the switch issue like they are with a Remicade product. That's why for some of these more chronic diseases, the provider incentives are so critical. Where biosimilars are having more success, it's because physicians are, frankly, having an easier time prescribing the biosimilar because there's less resistance.

CfB:What are your key takeaways from the report and the current landscape for biosimilars? Meaghan, would you like to go first?

 Sure. Thank you, Tony. I think this was another piece of evidence and another analysis that shows how biosimilar competition can benefit patients with decreasing prices and lowering health care costs and that more competition equals increased health care savings. That's an area where we're going to be focused on trying to increase health care savings and lowering health care costs with more competition.

 I think this study contributes to the conversation that's going on about how much potential there is for competition in this market. Second of all, to the extent that the experience with biosimilars is different from that of [generics and the] Hatch-Waxman Act, which is, in a sense, the model for the BPCIA, what [potentially] accounts for that? I think the evidence that we've put together, so far, is (1) there's potential here for the market and we have to give it some time to evolve along the lines that Meaghan pointed out. The second thing is that there are clearly impediments to entry. Even after you've met all the standards for approval, there are still impediments to even getting into the market. I think those need to be addressed in regulation and potentially other competitive practices on the payer and antitrust side. I think those are, in a sense, where we think the state of play is right now.

Richard G. Frank, PhD, and Meaghan Rose Smith discuss a recent white paper on the regulatory and anticompetitive impediments to biosimilar market entry and the hope for biosimilar savings.

Dr Richard Frank and Meaghan Rose Smith Discuss “Friction” in the Biosimilar Market

Here are the top 5 biosimilar articles for the week of March 29, 2021.

Number 5: Samsung Bioepis is reporting that its adalimumab biosimilar Hadlima has been 

Number 4: EirGenix, in partnership with Sandoz, announced 

 results for its trastuzumab biosimilar in patients with breast cancer.

Number 3: Biosimilars get short shrift in a 

 developed by the Drug Pricing Lab at Memorial Sloan Kettering (MSK), experts say.

 on how biosimilar educational materials should instill confidence in these medications and which policies may be more harmful than beneficial.

Number 1: A renowned expert on the life sciences industry in the United Kingdom provides an 

 at Brexit and the importance for the pharmaceutical sector.

The Top 5 Biosimilar Articles for the Week of March 29

Here are the top 5 biosimilar articles for the week of March 22, 2021.

Number 5: Peter Bach, MD, MAPP, and his Drug Pricing Lab at Memorial Sloan Kettering (MSK) argue profit caps 

Number 4: Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently 

 to satisfy international regulatory requirements, investigators conclude.

Number 3: Biosimilars are intended to save money for the health care system, but for many reasons, they are 

Number 2: AbbVie, the maker of originator adalimumab, has 

 against biosimilar developer Alvotech for unlawful receipt of trade secrets related to the production of its very successful high-concentration adalimumab formulation.

 to register its planned biosimilar and women’s health products spinoff as a publicly traded stock corporation.

The Top 5 Biosimilar Articles for the Week of March 22

 I'm Tony Hagen, senior editor for The Center for Biosimilars®. Biosimilars are valuable tools for saving money and improving access to care. But using them requires care in storage, records management, payer interactions and procurement. To help pharmacy teams get this process right, the NCCN [National Comprehensive Cancer Network] Pharmacy Directors Forum put together a set of recommendations on safe and efficient use of biosimilars in the clinical setting. The NCCN forum also called for bringing an end to single biosimilar payer policies, which they feel are too restrictive. We spoke to a co-lead on the paper, Kenneth Komorny, the chief of pharmacy at Moffitt Cancer Center. Dr Komorny worked with a team of 10 others, including Ryan Roux, vice president of pharmacy at the University of Texas MD Anderson Cancer Center.

CfB:When talking about the risks of using biosimilars, in the NCCN paper, you say that you don't mean to discourage the use of these products. More specifically, you want to emphasize the need for attention to detail for doing things carefully. Can you elaborate on that thought?

That's absolutely true. By no means did we intend to discourage those products. All of the members on the workgroup support the clinical use of biosimilars with careful attention, as you said, to some of the major risk points that we highlighted. Unfortunately, there's a misperception that no additional work is needed in using biosimilars and that there are really no risks from an operational standpoint of utilizing multiple biosimilars. As highlighted in our paper, that couldn't be further from the truth. There are many moving parts. There's an awareness of those risk points. It's important to establish a solid strategy around those risks to avoid process failures and really to ensure a best practice. So, that was our intention with the paper.

CfB: The pharmacy directors team at the NCCN believes that a legislative solution may be the best answer to payer single-biosimilar policies. Can you explain?

Sure. The need to process different brands of the same medication to different patients on the same day leads to risks, as we discussed in the article. When a payer selects only 1 of many biosimilars and they only will pay for that one, and then another payer selects a different biosimilar of that same medication, that truly serves as the root cause to that problem. We have very strong relationships with some of our payers and we negotiate and collaborate on initiatives that are important to them. At the same time, they work with us to assure that we can provide that care in a safe manner. But other times, honestly, there's less interest in collaboration. In those cases, legislation may be necessary to intervene on potentially unsafe policies. So, I guess I wouldn't say that it's the best answer in all situations, but it may be the only answer in certain circumstances.

CfB: How prevalent is single-biosimilar policy in the payer world?

So, I can tell you from our perspective, from Moffitt's standpoint, at this point with our major commercial payers of all the medications that have biosimilars, we have 1 mismatch currently between our default formulary biosimilar and all of our payers. I feel like we've done a good job at balancing that. I'll also say that a vast majority of our payers have more than 1 biosimilar that they will allow for payment. That gives health systems the flexibility of picking and choosing those biosimilars that we can use consistently across our patients, regardless of which payer they have.

CfB: If you were to design legislation that would alleviate this bottleneck and make more biosimilars available for providers to work with, how would that legislation read?

I think at its core, really, the highest likelihood for an error is when we're processing different biosimilars for different patients, as I just described. I think the prevention of single sourcing, where payers only pay for 1 biosimilar of a medication, has to be critical to any legislation that would come forward, because again, that is the root cause to those variances in process and procedure that we have that lead to errors.

CfB: Do payers appear not to be able to negotiate or resolve this issue without some sort of legislative mandate?

Yes. I think that would be that would be the last alternative, right? If we were able to work with one another to mitigate some of those risks—and that's what we do. We take every effort to try to work with our payers to sort out a resolution that's good for them and good for us, because our primary interest is the care of the patients and assuring that we're treating them the way they need to be treated at that highest level. I think that's what the white paper does. It establishes what some of those best practices look like and how we can provide the highest level of care for our patients.

CfB: What are some of your other recommendations for enabling health care institutions to get the biosimilars they want to the head of the queue?

Well, I think it rests on a robust formulary management system That's critical to optimizing medication use and medication safety within a health system. The formulary review needs to be thoughtful and involve safety, clinical, and economic considerations. But with the biosimilars, it also requires close payer coverage assessments. So, I think, as illustrated in the paper, an upfront as well as an ongoing payer policy coverage review is essential. What we look for in the core of our formulary processes [is] to identify those biosimilars that are covered by the greatest number of major payers to maximize consistency and create the least number of variations in the process. As I mentioned, today, we have 1 mismatch between 1 of our payers and 1 of the medications that has a biosimilar. And although we need to treat that as an exception, which is a convoluted process and we have to spend extra attention to detail to assure that mistakes are not made. That's manageable.

CfB: When you say it's a mismatch, you mean the payers' formulary does not permit the biosimilar that you prefer?

So, when we first experienced this a couple of years ago, we worked with our Process Excellence department here at Moffitt and we created a workflow process. There are 32 steps in that workflow process. It's a legal-size piece of paper that has the process for managing a mismatch of the drug to payer per patient. So, we have to walk through those steps, and it involves lots of different areas within our hospital involving IT [information technology], our financial clearance unit, managed care department, our pharmacy, our providers, and our nurses. We go through that checklist to ensure that we follow those steps properly. As I said, when it's 1 payer and 1 drug, is very time consuming—it’s worthwhile time spent—to prevent mistakes from happening, but it occupies a large part of our time working on that 1 patient. I just can't imagine if we had multiple mismatches across multiple different biosimilars. Again, that's why our recommendations are listed within the paper, to help mitigate some of that risk.

CfB: Earlier you described making sure you had a clear understanding within your institution which biosimilars were preferred and that you avoid mistakes. Is that something that the NCCN strongly recommends, making sure all process flows are clarified and that everybody is on the same page, and that they have access to systems that reveal the data necessary to make the right choices?

That's exactly right, Tony. The work of the recommendations of meeting with your financial clearance unit, your revenue cycle departments, meeting regularly with managed care to identify policy changes, and working proactively with the payers as those changes come forth, those are critical to the success of best practice and operationalization of biosimilars. So, you hit the nail on the head there, yes.

CfB: So, in the biosimilar procurement process, I got the impression from the paper that there's a little bit of wasted effort. The NCCN was recommending a streamlining. Can you explain what was meant there?

From the procurement standpoint, there was a lot of discussion in some of our early meetings, as we were talking about risk points from a procurement standpoint of not being able to receive the drug. And the context of that is when a drug is first available, it has to be stocked at the wholesaler and par levels have to be established.

So, at times, an institution may be ready to switch to a product or to start ordering a product and the wholesaler doesn't have it. There are other situations in which a wholesaler may stock that medication, but if 1 institution has been ordering that medication and now, 10 institutions are ordering that medication, they just don't have the stock on hand to be able to supply, and it could lead to a shortage-type situation. Those are usually fairly short term and those resolve over a period of time. Wholesalers figure out how much drug they need to keep on their shelves. So, short-term, it's certainly a risk, but for long-term, it's less of a risk. When we did the evaluation of the survey and the risk points, procurement really didn't receive discussion in the paper because of some of the other areas that we needed to focus on.

CfB: [In regard to] failure modes, you had a huge chart in your paper that explained the many ways that you could go wrong during the process. It seems very tricky. Can you elaborate on these issues and perhaps explain a bit more about how to get things right the first time and save money?

A failure mode effects analysis [FMEA] is a wonderful tool for identifying what you should really focus on from a risk standpoint. The content expert that developed the FMEA that was in the paper from her institution identified various areas and scored those areas. So, when evaluating severity occurrence and detection of those risks, if the institution does that FMEA, they will have a clear picture of their first, second, and third areas to focus on from a risk standpoint. That was performed, as I said, at her institution, and that was consistent with the risk factors that were identified through the survey and that we focused on in our white paper. But I think the purpose of that failure mode effect analysis process is what we would recommend institutions to do to help find out at their institution what are some of the risk points that need to be identified first. So, that's part of our recommendation.

CfB: What's at stake if you don't follow these recommendations to the letter?

The best practices that are described in this white paper will help minimize defects in the process for operationalizing biosimilars. Some of the primary failure points that we identified—medication errors, inefficiency, financial toxicity to both patients and to institutions—these best practices lead to less variation in the process, which will lead to less defects. When you're talking about defects in the process of high-risk oncology medications, [these] can lead to significant outcomes and they can be catastrophic for some patients. 

So, our goal with this white paper is to share with other institutions how to design a process around biosimilars which will improve safety, improve efficiency, and decrease the financial toxicity to patients so that patients can be treated for their cancer in the best possible means. We feel that these recommendations are our best practice.

CfB: Tell us a bit more about the survey and how it was designed to get at the issues you thought were important in the use of biosimilars.

Sure, Tony. This survey was developed by the Pharmacy Directors Forum Workgroup, a subgroup of the Pharmacy Director Forum through NCCN. The workgroup identified pharmacy leaders that evaluated different risk points at their institution. That feedback was then used to create a survey. There were 9 areas that were highlighted as potential risk points. And then, there was 1 free text box in that survey that allowed any other risk points to be highlighted if it was deemed appropriate. The survey was then sent to the entire NCCN Pharmacy Directors Forum and we had 14 out of 28 [respond to] that survey.

Based on the survey results, we prioritize the highest scoring risk factors, and that included payer restrictions, leveraging the HR [human resources], billing issues, storage issues and safety concerns. And then, that survey served as the foundation for the risk points that were highlighted throughout the paper.

Kenneth Komorny, PharmD, BCPS, was a co-lead on development of National Comprehensive Cancer Network (NCCN) recommendations for biosimilar management. He explains some of the positions the NCCN has taken.

Moffitt Chief Pharmacy Officer Discusses NCCN Biosimilar Recommendations

Here are the top 5 biosimilar articles for the week of March 15, 2021.

Number 5: "Shocked" by the threat of competition, originator manufacturers start 

 long before rival products appear on the scene, investigators found.

, and Samsung Bioepis gets closer to marketing an adalimumab biosimilar.

Number 3: Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are 

 that favor originator drugs, the Association for Accessible Medicines (AAM) argues.

Number 2: Pfizer said it has made a business decision to 

 of biosimilars at a $350 million plant it built recently in Hangzhou, China.

 requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.

The Top 5 Biosimilar Articles for the Week of March 15

Why is Minnesota a good place to try a bill of this type, especially since it's the first of its kind in the country?

Well, I think Minnesota is a great place, because number 1: we like to be a state of innovation. Whether it be education or in other areas, Minnesota is an innovator. Secondly, we are a hotbed of excellent health care. And I'll give a shout-out to the Mayo Clinic, which is in my district in Rochester. We have a number of gold standard health care providers in our state. We also are a state known for medical innovation, and so a medical ally comes to mind. So, Minnesota is the place to do this. And I'm very proud of the fact that our first biosimilar bill actually passed before we even had 1 biosimilar in our nation. And the point is, we should be on the cutting edge of this and Minnesota can lead. It will be great for our citizens and it will also be great for those [companies] who will continue to [develop] those biosimilars that will have the same outcomes, but at a much lower cost.

What are the politics involved here and are you feeling any pushback from the payer or manufacturer community?

There's always pushback to change, and the key is really listening to those objections—really trying to sort out which ones are objections that matter, [such as] how is it affecting the patient? How is it affecting the doctor-patient relationship? How is it affecting the cost and the choice? So, those are the things that really come to the front. I'm very pleased with the language we have in [the bill, addressing] wholesale cost and covering biosimilars that are at a lower cost. I think those are 2 really key pieces that are going to help drive this to fruition and actually incentivize more biosimilars and get lower-cost of drugs to our patients on time without needing to go through the delay of prior authorization. And I think our medical providers will appreciate as well that these things are covered on the formulary, so they don't have to go through the cycle of paperwork for things like prior authorizations.

To hear about this bill from State Representative Jennifer Schultz, co-author of SF 990, click 

State Senator Carla Nelson explains how the pharmaceutical industry is reacting to her bill requiring payers to cover all approved biosimilars and reference products.

Minnesota State Senator Discusses Pushback to Groundbreaking Biosimilar Coverage Bill

Here are the top 5 biosimilar articles for the week of March 8, 2021.

Number 5: Alteogen, a Republic of Korea-based biopharmaceutical developer, said it has 

 a phase 1 clinical trial of an aflibercept biosimilar referencing Eylea.

Number 4: Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, discusses 

 that affect use of biosimilars in oncology.

 show that oncologists are embracing biosimilars not just in supportive care but for therapeutic uses also.

Number 2: A study of comparative clinical efficacy trials for biosimilars suggests that these trials are often larger and as rigorous as those done for originator products, and 

Number 1: Minnesota legislators introduce what could 

 law to curtail payers' rights to determine which biologics patients have access to.

The Top 5 Biosimilar Articles for the Week of March 8

Joseph Alvarnas, MD, is a hematologist and oncologist and an expert in bone marrow and stem cell transplantation at City of Hope in Duarte, California, where he serves also as vice president of Government Affairs and senior medical director for Employer Strategy. He is also a clinical professor in the Department of Hematology and Hematopoietic Cell Transplantation. He spoke with Tony Hagen, senior editor for The Center for Biosimilars®, about biosimilar use at his institution.

Joseph Alvarnas, MD, a recent presenter at the Association of Community Cancer Centers annual meeting, discussed efforts to implement biosimilars at City of Hope, a clinical research center, hospital, and graduate medical school in Duarte, California.

Joseph Alvarnas, MD, Discusses Biosimilar Use at City of Hope

At the Association for Community Cancer Centers’ 47th Annual Meeting & Cancer Center Business Summit (AMCCBS), we spoke with Lalan Wilfong, MD, a medical oncologist/hematologist and executive vice president of Value Based Care and Quality Programs. At the AMCCBS Virtual 2021 meeting, Dr Wilfong spoke about improving patient outcomes in cancer. We talked with him about the challenges of integrating biosimilars in a large network of physicians and how that was accomplished.

Lalan Wilfong, MD, an expert on value-based care, explains how Texas Oncology worked with physicians and payers to make biosimilars available for patients.