Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27.
Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York.
Ashkenazi kicked off the session by providing a background of the Safe Harbor Act, which in the biosimilar space offers a company protection from potentially infringing on patents if the sole use for the production of a patented product is deemed “reasonably related” to the development and submission of information to the FDA for the manufacturing, use, or sale of drugs.
During his presentation, Ashkenazi discussed the recent court dealings in the Amgen v Hospira case. In the case, filed in September 2015, Amgen sued Hospira for excess lot production of a potential epoetin alfa (Epogen) biosimilar. The jury found that the Safe Harbor Act did not apply to 14 of the 21 batches the developer manufactured, awarding Amgen nearly $70 million in damages.
Ashkenazi closed his presentation asking that the audience consider a hypothetical not yet seen in a court of law, but a potential hot button issue: if a company is manufacturing a product utilizing the Biologics Licence Application approval pathway that does not infringe patents, but continues the development efforts to seek approval for an additional indication, does Safe Harbor apply?
During his presentation, Morris provided an in-depth look at the many settlements and potential launches surrounding potential adalimumab (Humira) biosimilars. There have been a few biosimilar patent battles over the launch of potential biosimilars. Specifically, in August 2016, AbbVie sued Amgen after briefly participating in the patent dance. In September 2017, the companies reached a settlement that Amgen’s Humira biosimilar will have a US launch date of January 2023, and a European launch of October 2018.
In addition, AbbVie’s suit against Samsung Bioepis over disputed patents resulted in a similar settlement. Bioepis’ biosimilar, not yet approved by the FDA, will not be allowed to enter the market in the European Union until October 2018, nor the US until June 2023. Recently, Patients for Affordable Drugs called on the Federal Trade Commission to examine whether this pay-for-delay deal violates anti-competitive and antitrust laws.
Though the biosimilar area is facing many different forms of litigation, presenters agreed that manufacturing processes and method of treatment patents are dominating the landscape at the moment. In addition, some other key takeaways are that many companies are not completing the patent dance, and IPRs have become an additional part of biosimilar litigations.
The panel left a key question for the audience to answer: Is it better for a biosimilar manufacturer to disclose more information upfront, or rather abstain from the patent dance entirely?
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.