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Pharmaceutical Industry › aBLA › Prescription Drugs

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

American Conference Institute (ACI) on

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

Goodwin on

On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

Venable LLP

Celltrion Submits aBLA for CT-P39, Proposed Interchangeable Biosimilar of Xolair® (omalizumab)

Venable LLP on

On March 10, 2024, Celltrion announced in a press release that it submitted an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P39 (omalizumab), a proposed interchangeable biosimilar of Genentech’s /...more

Venable LLP

Accord’s aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA

Venable LLP on

According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab), a proposed biosimilar to Janssen...more

Goodwin

Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars

Goodwin on

On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and...more

Goodwin

Accord BioPharma Announces the Acceptance of BLA for HLX02 (a proposed trastuzumab biosimilar) by FDA

Goodwin on

On April 5, 2023, Accord BioPharma announced that the FDA has accepted the Biologics License Application (BLA) for HLX02 referencing HERCEPTIN (trastuzumab) for adjuvant treatment of HER2-overexpressing breast cancer and...more

Goodwin

DEAL WATCH: Biosimilars, Biosimilars and More Biosimilars

Goodwin on

It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a...more

Mintz - Health Care Viewpoints

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

Mintz - Health Care Viewpoints on

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Goodwin

Coherus Submits 351(K) BLA Application to FDA for Pegfilgrastim Biosimilar

Goodwin on

Coherus Biosciences, Inc. announced submission to the FDA of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Pegfilgrastim is used to prevent or treat neutropenia, a...more

McDonnell Boehnen Hulbert & Berghoff LLP

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

McDonnell Boehnen Hulbert & Berghoff LLP on

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

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