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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments. 314.150(c).

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Better Late Than Never: FDA Published FR Notices For De Novo Classifications Dating As Far Back as 2013

FDA Law Blog: Biosimilars

This editorial change began in December 2019 to indicate that the document amends the Code of Federal Regulations. By Véronique Li, Senior Medical Device Regulation Expert — In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). What are the latest amendments?

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog: Biosimilars

According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. RE 44,599 and RE 44,638 were submitted nearly ten years ago (a point not lost on Gilead as noted below), on September 17, 2014 (Docket Nos. Our second example follows the same pattern as the first example above.

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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog: Biosimilars

OHT-7’s well documented meltdown during the COVID-19 public health emergency should serve as an object lesson. 2, 2014), [link]. [12] Even if MDUFA VI were to allow the hiring of a significant number of new personnel, implementation of the Proposed Rule would begin before those employees arrive. 31, 2023), [link]. [10] 11] Jeffrey N.