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Biosimilar Regulatory Roundup: September 2018


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.

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