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Pharmaceutical Industry › Teva Pharmaceuticals › Biologics

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...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

Goodwin

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

Goodwin on

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 AVT05, a Golimumab Biosimilar

Goodwin on

​​​​​​​On January 27, 2025, Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. This marks the first U.S. BLA acceptance for a...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

Goodwin

Biosimilar Regulatory Approval Updates

Goodwin on

​​​​​​​Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more

Goodwin

Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Goodwin on

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more

Herbert Smith Freehills Kramer

DC District Court Provides Guidance as to the Meaning of ‘Protein’ Under the BPCIA

Herbert Smith Freehills Kramer on

In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more

Patterson Belknap Webb & Tyler LLP

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

Patterson Belknap Webb & Tyler LLP on

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

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