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On 14 April 2026, the US Court of Appeals for the Third Circuit published its judgment confirming the District Court’s decision to refuse to grant a preliminary injunction to prevent Samsung Bioepis from supplying its biosimilar ustekinumab to Cigna’s Quallent.

The d...

On 14 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastat...

On 2 April 2026, Taiwan-headquartered Lotus Pharmaceutical announced that it has entered into an agreement to acquire Sandoz AG’s Philippines business.  The acquisition is expected to be completed in Q2 2026, subject to closing conditions.

On completion, Lotus will u...

On 13 April 2026, Daiichi Sankyo announced that the FDA has accepted for priority review a Biologics License Application (BLA) for Daiichi Sankyo/MSD’s ifinatamab deruxtecan (I-DXd) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) with disease pro...

On 13 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the European Commission for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with inadequate response to histamine-1 antihi...

On 11 April 2026, BioNTech reported positive results for BioNTech and DualityBio’s investigational antibody drug conjugate, BNT323/DB-1303 (trastuzumab pamirtecan) in a Phase 2 cohort of patients with HER2-expressing, advanced endometrial cancer.  The results are part...

On 10 April 2026, Replimune announced that the FDA had issued a complete response letter (CRL) to its BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.  Sushil Patel, Ph.D., CEO of Replimune said, “As we previously...

On 10 April 2026, Apotex announced that it received the first US FDA Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, a generic version of Novo Nordisk’s Ozempic®.  FDA Tentative Approval signifies that Apotex’s product meets all...

On 1 April 2026, Shanghai Henlius Biotech announced that its Investigational New Drug (IND) application for HLX319, biosimilar to Genentech/Roche’s Phesgo® (Perjeta® (pertuzumab), Herceptin® (trastuzumab) and hyaluronidase), has been approved by China’s National Medical Pro...

On 9 April 2026, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), was approved in Australia in the following forms:

45 mg/0.5 mL solution for injection vial;
90 mg/1 mL solution for injection pre-filled syringe;
45 mg/0.5 mL solut...