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On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®.  Ranluspec® is approved in both vial and pre-filled syringe presentations for the treatment of nAMD, macular oedema following retinal vein occl...

On 2 June 2026, South Korean-headquartered Daewoong Pharmaceutical and Chinese-based global biologics contract development and manufacturing organisation (CDMO), Chime Biologics, announced that they have entered a strategic partnership agreement for the development, manufac...

On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®, seeking all approved reference indications.  Celltrion is also planning regulatory filings for CT-...

On 1 June 2026, BMS announced that the European Commission has approved Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adults and adolescents over 12 years of age with previously untreated Stage III or IV classica...

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct sales.

The launch follows a settlement agreement between Samsung Bioepis and Regeneron/Bayer in relation t...

On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as Poherdy® in the US and Europe), biosimilar to Roche’s Perjeta® (pertuzumab).  Hanbeiyou® is approved for...

On 29 May 2026, Replimune announced that, following collaborative communications with the FDA, the company and the FDA have aligned on a path for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination w...

On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin H...

On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab) label to include data demonstrating that the treatment inhibits the progression of structural joint da...