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Biosimilar Regulatory Roundup: April


April was a notable month for regulatory action on biosimilars in the United States, and for regulatory developments in Europe.

April was a notable month for regulatory action on biosimilars in the United States. This month, the FDA issued 3 Complete Response Letters (CRLs) for proposed biosimilars.

First, on April 5, Korean drug maker Celltrion announced that it had received CRLs for its proposed trastuzumab and rituximab biosimilars in the wake of a warning letter from the FDA concerning its manufacturing facility. Then, on April 23, Pfizer announced that it had received a CRL of its own concerning a trastuzumab biosimilar. Pfizer said that the FDA highlighted the need for additional technical information about its product.

These CRLs came as disappointments to some, as the FDA has been increasing its assurances that it is working toward approving more biosimilars; Leah Christl, PhD, director of the therapeutic biologics and biosimilars staff at the Center for Drug Evaluation and Research’s Office of New Drugs at the FDA, hosted a question-and-answer session on the website Reddit, in which she said that the agency is examining ways it can better provide clarity for biosimilar product sponsors and encourage biosimilar competition.

Speaking later in the month at the National Policy and Advocacy Summit on Biologics and Biosimilars held in Washington, DC, on April 17, Christl said that, while the US biosimilars market has not progressed at the same rate as it has in the European market, the US biosimilar pipeline is robust with respect to the applications currently being submitted for review.

Also this month, the FDA released its 5-year financial plan for its User Fee Acts, including the Biosimilar User Fee Act, which allows the agency to collect fees from product applicants for the review of proposed biosimilars. During 2018, the agency estimates that it will collect approximately $40 million in biosimilar user fees, and will carry over more than $48 million from the prior year.

The agency also made the case for increased funding; addressing the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, FDA Commissioner Scott Gottlieb, MD, said that the President’s budget request for 2019 (which proposes $5.8 billion in total resources for the FDA, or an increase of $633 million) would allow the agency to undertake a number of initiatives, including a program to modernize the review of generic drug applications as a way to increase competition, address high drug costs, and advance new approaches to support development of treatments for rare diseases.

The agency also finalized key guidance in April, with its guidance for industry on special protocol assessments (SPAs). Under such assessments, product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval. Protocols assessed under SPAs include those needed for biosimilar interchangeability studies.

April was also a busy month for regulators outside the United States; shortly after the European Medicines Agency (EMA) reallocated the United Kingdom’s portfolio of more than 370 centrally authorized medicines for which it had regulatory responsibilities, the United Kingdom announced broad plans for coping with medicines regulation after the nation’s withdrawal from the European Union. In its planning document, the UK Medicines and Healthcare Products Regulatory Agency indicated that it is planning to deliver a smooth exit from the European Union under any scenario, including the “very unlikely” scenario in which no mutually satisfactory UK—EU agreement can be reached.

Meanwhile, the EMA opened a public consultation period on the EU template for Good Manufacturing Practice noncompliance statements. The EMA proposes to revise its Compilation of Community Procedures on Inspections and Exchange of Information to separate the processes of risk assessment and risk control, accelerate public release of noncompliance statements, avoid giving conditional GMP certificates together with noncompliance statements, and provide specific guidance to facilitate the release of critical drug products. The consultation, open until May 15, 2018, seeks to collect relevant information from stakeholders to help the working group to develop a harmonized approach to dealing with the supply of medicines in cases of serious noncompliance.

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