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Prescription Drugs Biologics Teva Pharmaceuticals

Goodwin

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

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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

Goodwin

FDA Accepts U.S. Biologics License Application for AVT06, Alvotech and Teva’s Proposed Aflibercept Biosimilar

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On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to...more

Goodwin

Alvotech and Teva Announce Acceptance of BLA for AVT04, a Proposed Biosimilar to STELARA (ustekinumab)

Goodwin on

On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies...more

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Patterson Belknap Webb & Tyler LLP

The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma

When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner...more

Smart & Biggar

Rx IP Update - December 2016

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Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

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