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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. FDA’s position is, however, only one side of the story. Specific features of the PR will foreseeably yield new bases for challenge.

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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

. § 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R. Patent Nos.

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Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e.,

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AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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