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June 17th 2025
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BBCIC Seeks to Provide Stakeholders With Real-World Data on Biosimilars
May 24th 2018At the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, members of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) discussed the ways in which their organization, a not-for-profit entity that conducts postmarketing observational research to monitor biosimilars and novel biologics for efficacy and safety, is working to provide real-world evidence on these products to stakeholders.
FDA Releases Educational Video Series on Biosimilars
May 23rd 2018Yesterday, the FDA announced the release of a 5-part video series designed to provide viewers a background of what biosimilar and interchangeable products are, the development and approval process for these products, and the tools and technologies that are used to demonstrate biosimilarity.
FDA's Mike Blum, MD, MPH, Discusses Postmarketing Surveillance of Biosimilars
May 22nd 2018In a Monday workshop held at the International Society for Pharmacoeconomics and Outcomes Research’s 23rd Annual International Meeting, in Baltimore, Maryland, Mike Blum, MD, MPH, deputy director in the Office of Pharmacovigilance and Epidemiology at FDA, addressed the role of postmarketing surveillance in the US biosimilars market and the potential role of real-world evidence in interchangeable designations for biosimilars.
Regulatory Divergence From EMA Would Have Serious Consequences, Says UK Report
May 18th 2018Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.
FDA Names Companies That Restrict Access to Drug Samples for Generic Testing
May 17th 2018Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.
AAPS White Paper Provides Guidance on Analytical Similarity Evaluations of Biosimilars
May 17th 2018The American Association of Pharmaceutical Scientists (AAPS), a professional organization of 9000 scientists, has published a new white paper in The AAPS Journal that discusses the scientific and methodological considerations of the process of attribute and test method selection, criticality assessment, and assignment of analytical measures to the FDA’s 3 tiers of analytical similarity assessment for biosimilars.
FDA Approves Pfizer's Epoetin Alfa Biosimilar, Retacrit
May 15th 2018The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States.
FDA Withdraws Direct Final Rule on Biologics Inspections
May 10th 2018Last week, the FDA announced that it will withdraw a direct final rule that proposed to amend general biologics regulations related to time of inspection requirements and to remove some duties of inspector requirements. In its statement withdrawing the rule, the FDA indicated that it had received significant adverse comments related to its proposal.
FDA Issues New Form 483 to Biocon Over Bangalore Facility
May 3rd 2018Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.
European Regulators Are Open to Novel Strategies in Biosimilar Development, Review Finds
May 2nd 2018Though the European Medicines Agency (EMA) has instituted guidelines for the development of biosimilars, approval of these drugs is possible even in cases in which the guidelines are not followed, and even in which primary endpoints in studies are not met.
UK Regulator Releases Corporate Plan to Address Brexit Uncertainty
April 26th 2018The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its Corporate Plan for the coming 5 years. The plan seeks to address some of the uncertainty generated by ongoing negotiations between the United Kingdom and the European Union in light of the upcoming Brexit.
