Tagged as: FDA

FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars

As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic.  Today, FDA withdrew this draft guidance….

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FDA Announces New Draft Guidance on Meetings Regarding the Development and Review of Biosimilar or Interchangeable Products

On June 4, 2018, FDA announced the availability of a new draft guidance on formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products.  The draft guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products,” is available here.  FDA also…

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FDA Releases Two Draft Guidances on REMS

For certain drugs with serious risks, the FDA may require drug developers to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks.  For an overview on REMS click here.  We have previously reported that FDA received numerous inquiries from generic…

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Regulatory News Roundup

Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. Following comments from FDA, USP announced that it would not make any changes absent stakeholder consensus.  Last month, USP…

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FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

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FDA Approves Hospira's Epoetin Alfa Biosimilar (UPDATED)

For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product.  Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV…

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FDA Releases Five-Year Plans for User Fee Programs

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans “communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017 (BsUFA II), the Generic Drug User…

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