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We summarize some of the key takeaways from FDA's finalized transition plans.

In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®. On July 4, 2022, Xbrane announced that based on comments...

The complaint also alleges that the Company unilaterally changed the terms of the loans to require arbitration after the loans attracted regulatory scrutiny.

On February 18, 2022, in the first and second wave suits filed by AbbVie Inc. et al. (AbbVie) against Alvotech hf. (Alvotech) regarding an adalimumab biosimilar, AbbVie filed a motion to strike Alvotech's Final Invalidity and...

On July 19 and 20, 2023, the PTAB granted institution of IPR2023-00442, filed by Samsung Bioepis regarding Regeneron's Patent No. 10,130,681 which is directed to treating angiogenic eye disorders...

Last Friday, Alnylam Pharmaceuticals, Inc. ("Alnylam") filed new complaints for patent infringement in the District of Delaware

On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz's denosumab biosimilar of Amgen's PROLIA® and XGEVA®.

Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023.

On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. ("Alnylam") and Pfizer, Inc.

We previously reported on Janssen's complaint alleging that Amgen's filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about...

Mylan argues that the claims are invalid as anticipated and obvious in view of the prior art.

Earlier this week, the PTAB instituted inter partes review of two patents directed to methods of treating rheumatoid arthritis by subcutaneously administering tocilizumab and devices for subcutaneously administering tocilizumab, respectively.

As we reported last week, the Northern District of West Virginia court has ordered an expedited trial in Regeneron's aflibercept BPCIA case against Mylan.

The District of Delaware has issued a scheduling order, setting a trial for April 2024, in Bristol Myers Squibb's (BMS) patent case against AstraZeneca. BMS filed its complaint against AstraZeneca on March 17, 2022, alleging infringement of eight patents related to anti-PD-L1 antibodies.

The U.S. Patent and Trademark Office has granted institution in four inter partes review proceedings challenging Janssen Biotech's golimumab method-of-treatment patents, finding that petitioners demonstrated a reasonable likelihood of prevailing on at least one challenged claim. These IPR proceedings run parallel to ongoing BPCIA litigation between Janssen and biosimilar developers Accord BioPharma and Bio-Thera Solutions.

On June 21, 2022, the U.S. Department of Justice (DOJ) filed a complaint and settlement agreement in federal court alleging that a social media company is in violation...

On February 13, the House Budget Committee, voting 21-16 along party lines (Republicans in favor and Democrats opposed), passed a 2025 budget resolution. The bill does not expressly reference the Tax Cuts.

On March 26, 2026, mortgage provider Better Home & Finance and cryptocurrency trading platform Coinbase announced a partnership with Fannie Mae to offer Fannie Mae-complaint mortgages backed by cryptocurrency from borrowers as collateral.