From the FDA’s hearing on the Biosimilar Action Plan to European approval of the first pegfilgrastim biosimilars, September was a banner month in biosimilar regulation.
From the FDA’s hearing on the Biosimilar Action Plan (BAP) to European approval of the first pegfilgrastim biosimilars, September was a banner month in biosimilar regulation.
On September 4, the FDA held a public hearing on the BAP at its White Oak Campus with 27 speakers who addressed their hopes for and concerns about the plan. Many of those speakers used the opportunity to call for final guidance on demonstrating interchangeability of biosimilars with their reference products and to call for a reassessment of FDA guidance on biologics’ suffixes. However, some reference product sponsors took the floor to argue against interchangeability as a concept.
Also in FDA news, Celltrion announced that on October 10, the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application for CT-P10, a proposed rituximab biosimilar. Celltrion’s product is already approved in Europe for all indications (malignant and nonmalignant) of the reference Rituxan under the brand names Rituzena, Ritemvia, Truxima, and Blitzima. However, in the United States, it is not yet clear which indications of the drug will be up for discussion in the ODAC meeting, and it is rumored that Celltrion may not seek approval for all of Rituxan’s indications, given the complex US patent landscape.
The FDA will also begin review of another monoclonal antibody: Samsung Bioepis’ SB5, a proposed adalimumab biosimilar referencing Humira. The drug, which is approved in Europe as Imraldi and which is expected to launch in EU nations on October 16, is the latest challenger to AbbVie’s Humira; already approved in the United States are Boehringer Ingelheim’s Cyltezo and Amgen’s Amjevita, neither of which has launched.
Even as biosimilar challengers for Humira become more numerous, AbbVie faces legal challenges related to its originator adalimumab. The State of California has filed suit against the drug, alleging that AbbVie provided kickbacks to healthcare providers throughout the state to encourage them to prescribe Humira and used a network of registered nurses to mislead patients about the risks associated with the drug.
Meanwhile, in the European Union, the European Commission has authorized yet another adalimumab biosimilar: Mylan and Fujifilm Kyowa Kirin’s Hulio. The partnership said that it had reached a settlement with AbbVie that allowed it to obtain a license to market its drug in the European Union, and noted that it could launch the drug as soon as October 16.
Two supportive care biosimilars also received the Commission’s authorization this month. Coherus Biosciences received the all-clear to market its pegfilgrastim biosimilar, Udenyca, a drug that is also awaiting FDA review. Accord Healthcare also received the Commission’s approval for its pegfilgrastim biosimilar, Pelgraz, and plans to launch its product in the EU market as soon as national price and reimbursement activities have been completed.
Three more pegfilgrastim hopefuls received positive opinions from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use: Sandoz, Cinfa, and Mylan will all have their respective products reviewed by the European Commission for a final decision.
The EMA has also begun taking greater steps to educate the public about biosimilars; this month, the agency launched a new set of educational materials, available in 8 EU languages, that explain key features of biosimilar medicines and highlight the increased patient access that these products have provided to European patients.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
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.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.