The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application. Marjorie Shapiro, chief of the laboratory of molecular and developmental immunology at FDA, told attendees at the annual PDA/FDA conference in Washington, DC, that the first biosimi...

Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday. Bluntly put, Woodcock said biosimilar and other indu...

The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars. Background The IPRF was created as a safe harbor for discussion and promotion of harmonization among regulatory authorities and Regional Harmonization Initiatives (RHIs), including 11 regula...

The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label. Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the US from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen). The approval of Erelzi follows a unani...

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...

Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.” “In considering the totality of the evidence submitted, the data submitted by the Applicant [Sandoz] show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences i...

Competition for one of the world’s top-selling biologics – AbbVie’s Humira (adalimumab) – is likely to come in the near future, as staff at the US Food and Drug Administration (FDA) said Friday that Amgen’s biosimilar has “no clinically meaningful differences” with the US-licensed Humira, in terms of safety, purity and potency. Amgen’s biosimilar will go before an FDA advisory committee next Tuesday, and if it is eventually approved (FDA has a deadline of 25 September 2...

The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Revises Draft Biosimilar Guidelines, Drops Allowance of Parallel Trials The Central Drugs Standard Control Organization (CDSCO) of India has revised its draft biosimilar guidelines published earlier this year. While most of the document is unchanged, CDSCO has made notable amendments on how clinical trials must be run and the situations in which comparative studies ...

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May. Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015. Similar to FDA's other user fee programs, BsUFA is a ...

The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for biologics and biosimilars. The document, first published 1 June , suggested a shift in FDA’s proposal on biologic and biosimilar naming as it altered the number of random suffixes proposed by developers (fro...