Roy March, Chief Executive Officer, Eastdil Secured

As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape.

On January 12, 2026, AbbVie and RemeGen announced an exclusive licensing agreement granting AbbVie rights to develop, manufacture, and commercialize RemeGen's RC148 outside of Greater China.

On March 23, 2026, Bio-Thera Solutions announced an expansion of its existing partnership with Intas Pharmaceuticals for BAT2506, its golimumab biosimilar...

The parties completed their briefing on Biogen's motion in April, and Judge Williams has scheduled a hearing for May 17 at 1 pm EST.

On October 17, Governor Newsom announced that California will be launching the "first and only" state contracted affordable insulin.

On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42, a biosimilar referencing Regeneron's EYLEA.

On March 12, 2025, Celltrion announced the commercial launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen's STELARA® (ustekinumab), in the United States.

On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®.

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration.

On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application ("sBLA") for Dupixent (dupilumab)...

On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi)...

Explore the latest regulatory approvals, biosimilar launches, and patent settlements shaping the biologics market. From FDA approvals of groundbreaking gene therapies to strategic acquisitions and BPCIA litigation updates, discover how innovation and competition are transforming treatment access across oncology, immunology, and rare diseases.

In a recent publication we helped co-author, we examined ClinicalTrials.gov entries and their possible impact on informing potential subjects of their eligibility to participate in clinical trials.

Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy's Laboratories ("DRL") and Fresenius Kabi.

Allen Smith, Managing Partner, Mohari Hospitality

Approval of Celltrion's Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43...

On January 27, 2023, California Attorney General Rob Bonta announced an investigative sweep focused on mobile apps' compliance with the California Consumer Privacy Act.

Our recent client alert discusses President Biden's Executive Order Ensuring Responsible Development of Digital Assets.

A recently-published study reported that Celltrion's CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with...