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FDA Denies AbbVie’s Citizen Petition on Interchangeability
FDA has denied AbbVie’s Citizen Petition on interchangeability. Back in December 2015, AbbVie submitted a Citizen Petition to FDA requesting that the agency take certain actions regarding...
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Update on Ireland’s Framework Agreement
Last fall, we reported on Pfizer’s 30% price cut to Enbrel® (etanercept) to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines, which requires price reductions for...
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World Health Organization announces biosimilar prequalification project
The World Health Organization (WHO) announced today plans to launch a pilot project for prequalifying biosimilar medicines later this year. The project will initially focus on biosimilar versions of...
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AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability
The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With...
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FDA Seeks Comments on Evaluation of Proposed New Model for Reviewing BLAs
The FDA announced that it is soliciting public comments on the statement of work for the assessment of its proposed new model for the review of original Biologics License Applications submitted under...
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FDA Draft Guidance Describes FDA’s Current Thinking on Evaluating Analytical...
Last week, FDA issued its latest draft guidance on biosimilar products and implementation of the BPCIA. The draft guidance, titled Statistical Approaches to Evaluate Analytical Similarity, “describes...
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FDA Announces New Draft REMS Guidance
Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File...
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FDA Releases New “Refuse to File” Guidance
The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and...
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FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards
The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in...
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FDA Publishes Best Practices for Communication Between IND Sponsors and FDA...
Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance is intended to...
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FDA Offers Perspectives on Enhancements to the Application Review Model
In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a...
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“Deemed to be a License” Provision Poses Potential Issues for Biological...
The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation...
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FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on...
FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization...
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FDA to Issue Draft Guidance on Interchangeability by End of Year
Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA). The FDA heard from a wide spectrum of stakeholders, including...
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Regulators Highlight Differing International Biosimilar Regulations;...
Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as...
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Guidance on Biosimilar Submission Requirements in Canada
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission...
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Goodwin Publishes Biosimilars Patent Litigation Update, Biosimilars...
Goodwin announced today the release of its 2016 BPCIA Litigation Update and Thinking of Investing In a Biosimilars Product? The 2016 BPCIA Litigation Update recaps a busy year in the legal world of...
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FDA Releases Biosimilar Naming Guidance
FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and...
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FDA Offers Perspectives on Enhancements to the Application Review Model
In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a...
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“Deemed to be a License” Provision Poses Potential Issues for Biological...
The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation...
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