Article
FDA Approves BMS's BREYANZI As First MZL CAR T Therapy
On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb's BREYANZI (lisocabtagene maraleucel)...
Goodwin Procter LLP
- Article
FDA Approves Sandoz Denosumab Biosimilars
On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen's XGEVA and PROLIA.Goodwin Procter LLP - Article
Switching Study Concludes That Transition From Humira To Samsung Bioepis's Adalimumab Biosimilar Is Safe And Effective
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie's Humira to Samsung Bioepsis's biosimilar adalimumab product...Goodwin Procter LLP - Article
PTAB Issues Final Written Decisions Finding Claims Of Recombinant Lentiviral Vector Patents Valid
On April 22, 2024, the PTAB issued final written decisions in IPR2023-00070 and IPR2023-00074, filed by Bluebird Bio on two patents related to recombinant lentiviral vectors...Goodwin Procter LLP - Article
Massachusetts Personnel Records Statute Amended to Require Employers to Notify Employees When Negative Information Is Placed in Personnel Records
Massachusetts recently enacted an economic development statute which contains an important amendment to the Massachusetts Personnel Records Statute, G.L. c. 149, § 52C.Goodwin Procter LLP - Article
Recent Delaware Case Highlights Common Pitfalls to Avoid With Earn-Out Provisions
Most people in the M&A business have encountered earn-outs in one form or another in attempting to structure transactions to close pricing gaps between buyers and sellers.Goodwin Procter LLP - Article
The Chevron Doctrine Is Dead. What Are The Implications For Business?
In June 2024, the U.S. Supreme Court overturned the long-standing Chevron doctrine, fundamentally altering how businesses interact with federal regulations.Goodwin Procter LLP - Article
Expected SEC Extension for 404 Compliance
Recent developments governing public companies and their officers, directors and investors. The Securities and Exchange Commission issued a press release last week announcing its intention to defer again the date for non-accelerated filers to comply with SEC rules adopted under Section 404 of the Sarbanes-Oxley Act.Goodwin Procter LLP - Article
Chinese Market Biosimilar Update
This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab).Goodwin Procter LLP - Article
EMA CHMP Recommends Grant Of Marketing Authorization For Three Biosimilars
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products.Goodwin Procter LLP - Article
European Biologics Regulatory Updates
Bayer's aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...Goodwin Procter LLP - Article
European Commission Approves Moderna's Updated COVID-19 Vaccine
On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna's COVID-19 vaccine Spikevax®.Goodwin Procter LLP - Article
The European Commission Proposes First Major Overhaul Of The EU Medicines Regulatory Framework In 20 Years
On 26 April 2023, the European Commission published two legislative proposals – a new Regulation 2023/0131 and a new Directive 2023/0132...Goodwin Procter LLP - Article
EMA Accepts Marketing Authorization Application For Alvotech's AVT06 (Aflibercept)
On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech's biosimilar of low dose (2 mg)...Goodwin Procter LLP - Article
SEC Grants Conditional Section 16(a) Exemption For Certain Foreign Private Issuers
On March 5, 2026, the SEC issued Release No. 34-104931, granting conditional exemptive relief from the Section 16(a) reporting requirements for directors and officers of certain foreign private issuers (FPIs).Goodwin Procter LLP - Article
Biosimilar Approval Updates In Europe And China
On April 25, 2024, the Committee for Medicinal Products for Human Use ("CHMP") adopted a positive opinion, recommending the granting...Goodwin Procter LLP - Article
Dr. Reddy's Secures License From Henlius To Market Daratumumab Biosimilar In The U.S. And Europe
On February 6, 2025, Dr, Reddy's Laboratories SA ("Dr. Reddy's") announced that it has entered into a license agreement with Shanghai Henlius Biotech...Goodwin Procter LLP - Article
EMA Recommends Denying Marketing Authorization For Prestige BioPharma's TUZNUE And HERVELOUS (trastuzumab)
In March, we reported that Prestige BioPharma had announced positive safety and efficacy results in a Phase III study for HD201.Goodwin Procter LLP - Article
FDA Accepts BLA For Shanghai Henlius Biotech's HLX11, A Pertuzumab Biosimilar
On February 2, 2025, Shanghai Henlius Biotech, Inc. ("Henlius") announced FDA acceptance of the Biologics License Application (BLA) for HLX11...Goodwin Procter LLP - Article
International Biosimilar Market Updates
Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe.Goodwin Procter LLP
