• Regulatory NewsRegulatory News

    BsUFA talks continue on technology, regulatory science and reviews

    The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.   During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (RELATED: FDA, Industry set priorities for BsUFA III , R...
  • Regulatory NewsRegulatory News

    New laws address NCE exclusivity, biosimilar education

    Two bipartisan bills aimed at clarifying what constitutes a new chemical entity (NCE) and providing education on biosimilars to consumers and physicians were signed into law by President Joe Biden on Friday.   The first bill, S. 415 , also known as the Ensuring Innovation Act , amends the Federal Food, Drug, Cosmetic Act (FD&C Act) to replace the definition of an active ingredient with the active moiety definition used by FDA for the purposes of determining whether...
  • Regulatory NewsRegulatory News

    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
  • Regulatory NewsRegulatory News

    Biosimilars industry weighs in on BsUFA II interim assessment

    Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.   The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication fo...
  • Regulatory NewsRegulatory News

    CDER missing more BsUFA target dates amid pandemic

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) faced a mountain of work and logistic challenges during the COVID-19 pandemic. While the agency met most of its user fee goals, its performance in moving original biosimilar applications along fell short of the pace it kept in other areas.   A new report from CDER tracks how well the agency fared in acting on applications by type and by quarter, looking at the last two quarters o...
  • Regulatory NewsRegulatory News

    OPDP's Gray reflects on 2020's challenges, successes

    Looking back to 2020, the acting director of the US Food and Drug Administration’s Office of Prescription Drug Promotion (FDA’s OPDP) highlighted the office’s major initiatives and successes.   Speaking in a “Conversations” interview hosted by FDA’s Center for Drug Evaluation and Research, Katie Gray, PharmD, spoke of inter-agency initiatives to encourage biosimilar competitiveness, how the pandemic changed the year’s course for OPDP, and future directions.   In th...
  • Regulatory NewsRegulatory News

    FDA offers new Q&A on biosimilars and interchangeable products

    In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars.   When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.   In the first of four questions and answers in the draft guidance, FDA explains how i...
  • Regulatory NewsRegulatory News

    FDA, Industry set priorities for BsUFA III

    At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US Food and Drug Administration (FDA) and industry shared their wish lists for the third iteration of the agency’s biosimilars review program.   While FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeab...
  • Regulatory NewsRegulatory News

    Testing requirements are likely slowing biosimilar entries in the US

    Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now a new analysis, published in the Mayo Clinic Proceedings , suggests that a “high testing bar” for biosimilars to gain regulatory approval is another contributing factor. The analysis found that the median time from the start of a Phase I study to approval by the US Food and Drug Administration (FDA) was more than 5 ye...
  • Regulatory NewsRegulatory News

    FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s Kanjinti (trastuzumab-anns), which is the fifth biosimilar to be approved for Roche’s Herceptin (trastuzumab) and 20 th biosimilar overall. Although none of the five Herceptin biosimilars have launched in the US yet, the first launches are expected soon. Roche has settled three court cases with Pfizer, Mylan and Biocon, and Celltrion and Teva. Roche also said publicly that it expects competition s...
  • Regulatory NewsRegulatory News

    FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names

    The US Food and Drug Administration (FDA) has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes. Since 2015, FDA has been adding the meaningless suffixes to biosimilars' nonproprietary names as part of an effor...
  • Regulatory NewsRegulatory News

    EU Takes Another Step Towards Adopting SPC Waiver Proposal

    The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.   Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and C...