Can President Biden succeed in his plan to rein in the soaring cost of prescription drug medicine? A blueprint for accomplishing this drawn up by HHS calls upon many ideas that are already familiar to stakeholders in the health care sector, including drug price negotiation, restrictions on pay-for-delay agreements, drug imports from lower-cost countries, and restrictions on product exclusivities for originator biologics.

These are sure to encounter headwinds in Congress and the biopharmaceutical industry, says Chad Landmon, JD, chair of 

Axinn, Veltrop & Harkrider’s Intellectual Property

, in an interview with Tony Hagen, senior editor for The Center for Biosimilars®.

Policy makers must be careful to ensure manufacturers get a healthy return on investment so as not to snuff out innovation: “We need to be careful about where we draw the line between innovation and drug affordability,” he says.

The HHS plan rests upon 3 pillars: making drug prices more affordable, stimulating competition among prescription drug makers, and fostering genuine innovation in medicines.

Lack of competition has allowed a trio of insulin makers to raise their US prices more than 1200% since the 1990s, 

. HHS also takes aim at “pay-for-delay” agreements between drug makers, which may extend exclusivity for originator biologics and generics, to the detriment of US health care consumers.

HHS may be able to work constructively with the FDA to accelerate drug application reviews and enable products to reach market sooner, but the Biden administration and HHS may run into difficulty when it comes to importing lower-cost drugs and negotiating drug prices, according to Landmon.

Importing drugs from a country with government-imposed price restrictions would be somewhat akin to importing price controls to a country with a free market for drug prices, and Canada, one possible source for prescription drugs, is already worried about potentially overwhelming demand from the United States, he notes.

HHS wants Medicare to negotiate drug prices “directly” with pharmaceutical companies and make those negotiated prices available to the commercial payer sector. This is an idea that may not succeed in the current political climate, Landmon says.

Also, an idea to shorten product exclusivity protections under the Biologics Price Competition and Innovation Act (BPCIA) could become a battle of some duration, given how long it took Congress to settle on the existing terms of the BPCIA, Landmon says. The FDA cannot approve a biosimilar or interchangeable biologic until 12 years have passed from the date of the reference product’s approval.

Videos

The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective. 

Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy

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 September 13, 2021.

Number 5: Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are 

 of Asia-Pacific (APAC) biosimilar development, according to a GlobalData analyst.

Number 4: Recent weeks have seen 2 India-based companies announce 

 by the Drug Controller General of India (DCGI), with much fanfare.

Number 3: In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contended that originator patents are not the 

 of a study of patients who switched between the company’s proposed high-concentration (100 mg/mL), citrate-free adalimumab biosimilar (AVT02) and the originator product (Humira).

Number 1: Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer a more "

,” according to Sarfaraz K. Niazi, PhD.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of September 13

Here are the top 5 biosimilar articles for the week of September 6, 2021.

Number 5: Policy developments, business milestones, and physician-led efforts to shape biosimilar absorption made August 2021 an 

Number 4: Animal toxicology studies still get included with biosimilar approval applications, although there are 

 that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explained the pros and cons.

Number 3: Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are 

Number 2: Kaiser Permanente got biosimilars into circulation by building physician confidence, a strategy that a Samsung Bioepis executive said 

 of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirmed biosimilarity.

The Top 5 Biosimilar Articles for the Week of September 6

Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health researcher who has long been an advocate for biosimilars. He has also developed guidelines in support of using biosimilars in the oncology space.

Is the interchangeable designation actually meaningful and necessary?

So, as I often mention, the United States is the only country that has a designation of interchangeability. Globally, this would have very little impact in meaning. I think the reason is that interchanging [of these agents] is driven by the originator's safety and efficacy data and acceptance by the professional oncology organizations. Just showing that you can switch from one to the other, once you've already said that the agent is safe and effective as the originator, I think there's been very little question raised. There still is a little bit of hesitancy, in general, about changing products in the middle of a course of treatment. So, if a patient has started adjuvant therapy with a biosimilar and has been told that they have to use a different one to complete their therapy, it just doesn't sit real well with clinicians. Why should they be forced to switch a product that seems to be working fine and the patient is tolerating well just because it's a little less expensive or they're being told [to do so] by their institution?

So, there is some pushback, and with regard to that, but in general, interchanging of these agents is already taking place. No biosimilar has been removed from the marketplace, either in Europe or in the United States, even globally, that I'm aware of, because of concerns over adverse events or loss of efficacy by changing from one agent to the other. So, and as I've said, many times, even the reference product that we prescribe of a biologic, the originator drug, is not the same drug today as it was 20 years ago. So, it's, in a sense, a biosimilar of itself sitting on the shelf right now. Saying that we can't switch or shouldn't switch because of cost or regional concerns just doesn't hold up very strongly in my mind. I think that pushback on this issue, while I understand it and the gut feeling of why change? When something's working don't fix it. I'm not concerned about the safety and efficacy of doing that.

Gary Lyman, MD, MPH, an oncologist and hematologist, explains that biosimilar substitution in the absence of interchangeability designations is widespread and not without clinical merit.

Dr Gary Lyman: Are Interchangeability Designations for Biosimilars Meaningful?

Here are the top 5 biosimilar articles for the week of August 30, 2021.

Number 5: Cipla, a medicines developer and retailer, and Kemwell Biopharma, a contract manufacturer, intend to 

 with Hikma Pharmaceuticals for the commercialization of a proposed ustekinumab biosimilar (BAT2206) for the treatment of chronic inflammation.

Number 3: The European Union has approved its 

 (Byooviz, SB11), a Samsung Bioepis product that references Lucentis.

Number 2: The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The 

 is conservative when it comes to substitution of these products.

Number 1: Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a 

The Top 5 Biosimilar Articles for the Week of August 30

Catherine Swick, MBA, senior vice president of Provider Strategy and Marketing at McKesson, recalls that oncology biosimilars have long been a part of the discussion, and once they became available, McKesson began working hard to promote their use.

“I would say that biosimilars, especially initially, were hard to accept, because people trusted that [original brand] drug they had been using for so many years, but once people got comfortable with the concept of [biosimilar] clinical similarity and what that really meant in terms of effective, safe patient care, we saw that transition happen quickly,” Swick said in an interview with 

McKesson provides back office, human relations, technology, and billing assistance, among other services, for the US Oncology Network, which encompasses 1400 physicians in roughly 60 oncology practices across 30 states.

“The US Oncology Network has put a massive amount of effort into switching to biosimilars over the last 18 months, and you can really see that in their results. We typically see 80% to 90% biosimilar adoption across the US Oncology Network,” Swick said.

Biosimilars have helped practices manage COVID-19-related financial pressure and continue to serve vulnerable populations, and the Oncology Care Model, the CMS value-based experiment in departure from the buy-and-bill style of health care practice, has made it even more important to use biosimilars, Swick said. “If you really want to succeed in the Oncology Care Model or any of your commercial value-based care contracts, switching to biosimilars is the right thing to do there,” she said.

At McKesson, education has been the main tool to get providers on board with prescribing biosimilars. “We’ve been beating the drum about clinical similarity and the fact that these biosimilars were coming for years now, so that helped pave the road toward them. Beyond that, [it has involved] a lot of education—practice by practice—and work with physicians, pharmacists, and nurses to help them understand the benefit of biosimilars, and also the safety and efficacy associated with them.”

Payers can play an important role in biosimilar adoption, although their prescription mandates, based on contracts with biologics supply companies, may interfere, according to Swick. These strip providers of their ability to choose therapeutic agents. Mandates based on pharmaceutical rebates may also foster inefficiency within practices, which may be forced to carry multiple preferred biosimilars or other biologics, leading to high inventory costs, waste, and the potential for error. Swick said she would like to see payers develop value-based care reimbursement models that align physician and payer incentives and encourage biosimilar adoption.

She expressed concern about the potential consequences of white bagging, under which drugs are delivered to practices by specialty pharmacies, adding an extra layer of management and complexity to the time-sensitive oncology treatment process. This trend has not yet emerged in the oncology sector, but it bears watching, she said.

“White bagging is a constant threat, I would say, to community oncology as a whole,” she said. “What white bagging does is it cuts out physician choice. It also separates what we have today, which is an incredibly efficient supply chain of the drug getting from the biopharma company to the practice in a timely, safe, fashion,” Swick said.

Catherine Swick, MBA, senior vice president of Provider Strategy and Marketing at McKesson, discusses efforts to get oncology biosimilars into play at US Oncology Network.

McKesson’s Catherine Swick Discusses Oncology Biosimilars 

Here are the top 5 biosimilar articles for the week of August 23, 2021.

Number 5: UnitedHealthcare (UHC) has changed its policy to indicate that the bevacizumab biosimilars Mvasi and Zirabev 

 in the treatment of certain ophthalmic conditions or considered ophthalmically equivalent to Avastin, the reference product.

Number 4: Rumors that HHS could calculate payment for biosimilars differently under a 

 have sparked concerns among providers and biosimilar developers. If the rumors are correct, the Medicare Part B payment methodology for biosimilars would be overhauled for the second time in 4 years.

Number 3: How many switches between a biosimilar and reference product will be sufficient to demonstrate that the 

? A virtual study verified the strength of FDA guidance.

Number 2: A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated 

Number 1: Use of the 351(k) biosimilar approval pathway 

, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggested that using the 351(a) pathway for standalone drugs and copy products may be faster and better in part 3 of a series.

The Top 5 Biosimilar Articles for the Week of August 23

What’s your take on payer formularies and how biosimilar placements on these preferred lists affect use at the physician level?

Well, the payer formularies and prioritization, in some cases, have a fairly profound impact on what drugs oncologists and other clinicians can use because it directly impacts the patient. Oftentimes, by prioritizing a certain therapy or certain biologic, a payer is saying that we will cover that and either not cover alternatives if you decide to not to use the favored agent or not pay at all. The burden is left either on the patient in terms of a much higher cost of care or is borne by the institution and the provider, which, of course, is not an attractive option either. 

So, in the end, although we talk about guidelines and how health care systems themselves have their own favorite agents, ultimately, they have to meld with the payer because of that reimbursement for these costly drugs. If [a drug] is not fully reimbursed, that directly impacts the patient and the provider. So, I would say it's a fairly dramatic effect.

Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how biosimilar placement on formularies affects physicians' willingness to prescribe these agents.

Dr Gary Lyman: Formulary Placements and Physicians' Biosimilar Prescribing Patterns

Here are the top 5 biosimilar articles for the week of August 16, 2021.

 is shaping up as a centerpiece of President Biden's effort to bring pharmaceutical prices under control. If drug companies won't negotiate prices, international reference pricing would kick in.

Number 4: The LAVENDER study demonstrated 

 of simultaneous intravenous (IV) administration of biosimilar trastuzumab (Kanjinti) and pertuzumab in cohorts of healthy volunteers.

Number 3: A retrospective study of rituximab biosimilars Truxima and Riximyo demonstrated 

 and survival for patients with diffuse large B-cell lymphoma (DLBCL).

Number 2: When it comes to their willingness to use biosimilars, providers and managed care pharmacists 

 on formulary placement and costs, according to a focus group study based on health care surveys.

Number 1: If biosimilars development and sales have lost some of their luster for Pfizer, it’s understandable, given the tremendous boost it received from its COVID-19 vaccine, and the company said its vaccine business is just getting started, with new contracts 

The Top 5 Biosimilar Articles for the Week of August 16

In an interview with The Center forBiosimilars®, Chad Pettit, MBA, executive director of Marketing and Global Biosimilars commercial lead for Amgen, discussed the company’s upcoming 2021 Biosimilar Trends Report, which will be released in September 2021. He also talked about the outlook for the biosimilar industry.

Earlier this summer, a preview of the report was released with observations on biosimilar market share and pricing trends at the wholesale and provider levels.

Looking at the infliximab marketplace, Pettit said the slow uptake of infliximab biosimilars is not a reflection on the health of the biosimilar industry. He expects that interest in biosimilars will increase as more reference products start facing biosimilar competition and more savings are achieved.

Pettit also explained that despite fewer biosimilar approvals in 2020 and 2021, compared with earlier years, the number of biosimilar development programs the FDA is working with has increased, suggesting that a new wave of biosimilar approvals and savings can be expected in the near future.

When asked about current discounts for biosimilars, relative to the cost of reference products, Pettit said price discounts for US biosimilars average 10% to 15% and are significant. He added that cost savings will grow as more competition leads to lower prices for both reference products and biosimilars.

However, Amgen’s July 2020 launch of Avsola (infliximab) on the US market at a 57% discount from the reference product (Remicade) raises the question whether competition is sustainable. It costs money to produce biosimilars and if prices drop too far, too fast, that could discourage manufacturers.

Pettit said that competition should be on a level playing field to ensure that manufacturers are able to invest and the industry is successful.

Although the COVID-19 pandemic diverted the FDA’s attention from biosimilars in 2020, and the number of approvals declined, Pettit is optimistic that this trend will reverse, especially as more competition emerges. He also highlighted pricing trends between different types of biosimilars.

In conclusion, Pettit said the upcoming Amgen report will show that biosimilar uptake and savings data are positive and encouraging. He said that biosimilars will be instrumental in creating sustainability for the biologics market and helping to offset the massive costs often associated with disease burden.

Chad Pettit, MBA, executive director of Marketing and the Global Biosimilars commercial lead for Amgen, discussed the company’s 2021 Biosimilar Trends Report and his projections for the future of the biosimilars market.