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Pharmaceutical Industry Food and Drug Administration (FDA) Interchangeability

Venable LLP

Spotlight On: Biosimilar Litigations - September 2024

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Venable LLP

FTC Submits Comment Supporting Proposed FDA Guidance Revising Switching Studies for Biosimilar Interchangeability

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On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more

Goodwin

FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

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​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

Venable LLP

FDA Accepts Bio-Thera’s aBLA for Proposed Stelara® (Ustekinumab) Interchangeable BAT2206

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On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability....more

Goodwin

FDA Issues Draft Guidance on Demonstrating Biosimilar Interchangeability

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​​​​​​​Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability....more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

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Venable’s BiologicsHQ Monthly Injection – June 2024...more

Venable LLP

FDA Revises Guidance on Switching Studies for Biosimilar Interchangeability

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On June 20, 2024, the FDA issued a draft guidance, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the need for switching studies to demonstrate a biosimilar is...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - May 2024

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Venable’s BiologicsHQ Monthly Injection - May 2024...more

Goodwin

Updates on Aflibercept Biosimilar Approvals and BPCIA Litigation

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Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI...more

Axinn, Veltrop & Harkrider LLP

Rethinking Interchangeability, Top Cases, and Battling Misinformation at FDLI’s Annual Conference

1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more

Goodwin

FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

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On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

Goodwin

Biden Administration Proposes Biosimilar Substitution Without Interchangeability

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​​​​​​​The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Three Interchangeable Biosimilar Drugs in 2024

After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this...more

Goodwin

Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA

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On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. SIMLANDI injection was approved for nine...more

Venable LLP

First High-Concentration Humira® Interchangeable, Alvotech and Teva’s Simlandi®, Approved in the U.S.

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On February 23, 2024, the FDA approved Alvotech and Teva’s Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie’s Humira® (adalimumab). Simlandi® is the tenth Humira® biosimilar to be approved, and the...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Another Interchangeable Biosimilar

Earlier this year, the U.S. Food and Drug Administration announced approval of Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech's Stelara (ustekinumab).  The drug was approved for...more

Goodwin

BYOOVIZ® (Ranibizumab-Nuna) Granted Interchangeable Status

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Recently, Biogen and Samsung Bioepis’s ranibizumab biosimilar (BYOOVIZ) was granted interchangeable status by the U.S. Food and Drug Administration. BYOOVIZ was deemed interchangeable to Genentech’s LUCENTIS for the treatment...more

Hogan Lovells

FDA ends interchangeability statement requirement for biosimilar labels

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The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any recommendation that...more

Venable LLP

New FDA Guidance Removes Interchangeability Statement from Product Labels

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On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. ...more

Goodwin

Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable Adalimumab Biosimilar

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On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a...more

Goodwin

FDA Releases Draft Labeling Guidance for Biosimilar Products

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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more

Goodwin

Is it Biosimilar or Interchangeable? It Won’t Be Easy to Tell Under FDA’s Latest Draft Labeling Guidance

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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA...more

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