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 August 1, 2022.

 suggested similar efficacy and safety of a denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.

 were up by 23% from last year, thanks to the success the company has had with biosimilars, of which revenues increased by 29%, and generic drugs, which had an increased revenue of 19%.

Number 3: Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were 

 by the FDA and the European Medicines Agency.

Number 2: Prestige Biopharma and Intas Pharmaceuticals 

 to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Number 1: Generic drug manufacturer Teva Pharmaceuticals would pay 

 more than 2500 lawsuits with states, local governments, and tribes over its role in the opioid epidemic under a settlement announced late Tuesday.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of August 1

Hi, I’m Hayden Klein 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 July 25, 2022.

Number 5: The first 2 years of a Providence St. Joseph Health program to increase biosimilar uptake and cut costs created 

 and “biosimilar adoption rates that greatly exceed the US national average.”

 it will launch a pharmacokinetic (PK) study of AVT03, a proposed biosimilar for 2 different formulations of denosumab, which is used to treat serious bone conditions.

Number 3: Prestige Biopharma and Intas Pharmaceuticals 

 to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals made a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Number 2: Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were 

Number 1: In recent weeks, Celltrion Healthcare 

 (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

The Top 5 Biosimilar Articles for the Week of July 25

Hi, I’m Hayden Klein 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 July 18, 2022.

Number 5: Abstracts from the European Hematology Association Congress 2022 confirmed 

comparable safety and effectiveness profiles

 between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.

Number 4: Two experts in biosimilar intellectual property (IP) law broke down the 

issues that digital health and precision medicine face

 with IP and the history of case law that has created the current landscape.

Number 3: The 2022 “Trends in Biosimilars Report Preview” said 

 from the use of biosimilars climbed to $3 billion in the second quarter of 2022, for a total of $18 billion over the past 6 years.

Number 2: A real-world study on Pfizer and Celltrion Healthcare’s infliximab biosimilar (infliximab-dyyb, Inflectra; CT-P13) demonstrated 

positive clinical and patient-reported outcomes

 in patients with inflammatory bowel disease in the United States and Canada.

Number 1: Posters from the American Society of Clinical Oncology’s annual meeting showed the 

 of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.

The Top 5 Biosimilar Articles for the Week of July 18

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

What should the FDA be doing to address the current backlog of inspections for biosimilar manufacturing facilities?

So, as we finished negotiations for the user fee, after that, we found out that biosimilar inspections were quite delayed. And unfortunately, if there's a delay in an inspection, there's a delay in approval of a biosimilar. And the biosimilar program inspections were the lowest—a little bit over 60%. So, we have multiple probe biosimilar applications that are not approved because the FDA did not do the inspection. Now, [we] completely understand about COVID-19, everything else, but what we're doing is advocating for the FDA—as part of user fees—we're advocating for the FDA to address this in a couple of ways.

One, FDA has a plan to do remote inspections. We're asking them to be sure that biosimilars inspections are always treated equitably, that we're not put on the bottom of the list and we're not deprioritized, and to use the process and procedures for remote inspections. The COVID-19 pandemic was tough, but we do believe that this won't be our first, unfortunately.

The other piece about the inspections, as we have heard from the FDA in our meetings, is that they plan to get all of the inspection backlog completed by the end of this year for fiscal year. So, we are cheering them on and also going to hold them accountable to do that, and especially with biosimilars because they're so important for patients and like we said cost savings. But yes, that's a key piece for us, to get those inspection backlogs up to date and completed for biosimilars.

Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections

Here are the top 5 biosimilar articles for the week of July 11, 2022.

Number 5: Some of the problems with use of 

 resemble those seen with all biologic drugs, while the authors say others are unique to the complexity of cardiovascular disease.

Number 4: A survey study found that many patients with breast cancer reported receiving 

 regarding switching from Herceptin to a trastuzumab biosimilar, with some patients reporting that they were never told a switch occurred or what a biosimilar was.

Number 3: During its annual conference in Sitges, Spain, Medicines for Europe recommended 

 for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.

Number 2: Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar 

 and weighs in on whether switching studies are necessary.

Number 1: As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its 

 for a batch of its insulin glargine biosimilar over missing labels.

The Top 5 Biosimilar Articles for the Week of July 11

Here are the top 5 biosimilar articles for the week of July 4, 2022.

Number 5: During its annual conference in Sitges, Spain, Medicines for Europe 

Number 4: So far in 2022, the United States has 

 in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.

of Shanghai Henlius Biotech's pertuzumab biosimilar candidate (HLX11), investigators found similar pharmacokinetic (PK), safety, and immunogenicity profiles between the biosimilar and the reference product (Perjeta).

 for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

Number 1: Shanghai Henlius Biotech announced the commencement of a 

 for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.

The Top 5 Biosimilar Articles for the Week of July 4

Julie M. Reed, the executive director of the Biosimilars Forum, explains what needs to be done to ensure progress on biosimilar legislation and lower drug prices.

Lowering drug prices seems to be the one issue Republicans and Democrats can agree on but efforts to do so, including ones that could increase biosimilar access, are often stalled. What needs to happen to get these policies implemented?

They need to be prioritized and we need action. When we have opposition against these bills, we hear from policymakers that they’re hearing the market’s working fine. That is, there's depth—several different lenses to look at how the market is doing. The market is working where there's robust competition and access because you're seeing that competition and access lower the prices and you're getting greater cost savings. That's the goal here.

Where the market is not working is if you don't have access or don't have robust coverage of multiple biosimilars; you are not seeing the robust pricing competition and cost savings. So, I think it's very important that when it has bipartisan support. We’re leaving cost savings on the table—and billions of dollars in cost savings. And I think we're not the only ones shouting this from the hilltops. Academics are shouting it, researchers are shouting it, legislators are shouting it, patient groups and providers are shouting, like, “Help us get access to biosimilars because we need to treat our patients and we need to have cost savings!” And so, we need action. We need the action, and I hope we see it.

Julie Reed Explains How to Push Forward Bipartisan Biosimilar Legislation

Here are the top 5 biosimilar articles for the week of June 27, 2022.

Number 5: Abstracts from the 2022 European Hematology Association (EHA) Congress presented 

 for 2 biosimilar candidates referencing Soliris (eculizumab): Amgen’s ABP 959 and Samsung Bioepis’ SB12.

 before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.

 of 2 biosimilar assets and start of development for 2 others provided hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.

Number 2: The European Committee for Medicinal Products for Human Use (CHMP) 

 for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.

Number 1: Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicled the current efforts to 

 from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

The Top 5 Biosimilar Articles for the Week of June 27

Although a lot of discussion regarding biosimilars has focussed on patient access, we need to divert more attention to the reliability of companies making biosimilar products, said Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis.

What types of conversations regarding biosimilars do we need to be have more of?

Patient access, we've heard a lot about. The other thing that we'd heard less about probably is the issues around surety of supply, which you get through having multiple manufacturers. But it's also an issue where you need to know that the companies sponsoring the products are reliable. And that's where I'd put one pitch in for Samsung Bioepis as if you've done the science right from the beginning, then everything else is an opportunity. And if you've got state of the art manufacturing. So, an issue that came out of COVID-19, of course, is reliability of the drug supply. And so you need to have capacity and you need it to be reliable.

Gillian Woollett Speaks on Where Biosimilar Conversations Need to Go Moving Forward

Here are the top 5 biosimilar articles for the week of June 20, 2022.

 for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

Number 4: Abstracts from the American Society of Clinical Oncology (ASCO) annual meeting took a look at the impact biosimilar 

substitution and increased biosimilar adoption

 had on spending within practices participating in value-based payment models and the Oncology Care Model.

Number 3: STADA Arzneimittel and Alvotech 

 of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra) in France, Germany, Finland, and Sweden, with more European countries to come.

Number 2: Not long after the company announced its 

 to promote access and increase adoption of biosimilars, Sandoz’ application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

Number 1: Iceland-based Alvotech announced that the pureplay biosimilars company is 