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  • Regulatory NewsRegulatory News

    US Supreme Court to Review Biosimilar ‘Patent Dance’

    The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole. T...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
  • Feature ArticlesFeature Articles

    Lessons Learned from Biosimilar Drug Development

    This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development. Introduction The US biosimilars market is at an interesting juncture, with one product launched (Sandoz's filgrastim biosimilar, Zarxio)...
  • Regulatory NewsRegulatory News

    EMA to Launch Tailored Biosimilar Scientific Advice Pilot

    The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...
  • Feature ArticlesFeature Articles

    Global Developments of Biosimilars

    This article was developed from presentations at the 2016 RAPS Regulatory Convergence meeting held in San Jose. The session titled "Biosimilars," was led by Arpita Shah, PharmD, senior manager, regulatory intelligence and policy, Celgene Corporation. Speakers included  Leah Christl, associate director, therapeutic biologics, FDA, CDER, Sabine Haubenreisser, MSc, PhD, EMA liaison official at the FDA and Tara Sanderson, associate director, project manager, CMC regulatory a...
  • Regulatory NewsRegulatory News

    US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches

    With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. “The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [ Biologics Price Competition and Innovation Act of 2009 ] and the ability of aBLA...
  • Regulatory NewsRegulatory News

    Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway

    Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away. “I can imagine this provision will be carved out, if you will…part of the problem with the ACA [ Affordable Care Act ] is that it became so big that it was hard to totally ...
  • Regulatory NewsRegulatory News

    WHO Releases Draft Guidance on Postmarket Changes to Biologics

    The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment. Specifically, the guideline, which covers both biologics (referred to as biotherapeutic products) and biosimilars (referred to as similar biotherapeutic products (SBPs)), details the procedures and data requirements for a ra...
  • Regulatory NewsRegulatory News

    FDA Officials Share Best Practices for Biosimilar Development

    With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs. The regulators' advice comes as the agency and industry prepare for the next era of FDA's biosimilars program under the second Biosimilar User Fee Act (BsUFA II) . According to Leah Christl, associate director f...
  • Regulatory NewsRegulatory News

    Biosimilar Interchangeability: ‘Careful What You Wish For’

    As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole. Ronny Gal, senior analyst in specialty pharmaceuticals equity research at Sanford Bernstein, told attendees at GPhA’s first biosimilars conference on Thursday that although...
  • Regulatory NewsRegulatory News

    Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key

    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...
  • Regulatory NewsRegulatory News

    Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar

    For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s blockbuster Enbrel (etanercept). Wednesday’s vote – 20-0, with no abstentions – comes on the heels of Tuesday’s 26-0 vote i n favor of approving Amgen’s biosimilar for AbbVie’s blockbuster Humira (adalimumab) . The discussion of Sandoz’s biosimilar was also less focuse...