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As previously reported, since November 2024, MSD has filed a number of petitions for review with the US Patent Trial and Appeal Board (PTAB) challenging the validity of patents relating to Halozyme’s MDASE™ subcutaneous delivery platform.  Halozyme has alleged in US court p...

On 8 September 2026, Sandoz announced that it is aiming to establish a portfolio of more than 100 biosimilars by 2040 as part of its Bio100 plan to maximise value in the “golden decade” for biosimilars.  According to Sandoz, over the next 10 years, medicines worth more than...

On 8 September 2026, Biocon announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has entered a 10-year contract to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertu...

On 4 September 2026, Business Standard reported that the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has given Roche a Phase 3 trial waiver for a high dose (920 mg) of Ocrevus® (ocrelizumab).  The waiver is conditional on Roche co...

On 4 September 2026, Daily Pharm Korea reported that South Korean-based Shin Poong Pharm has received Korean regulatory approval for Denovon™, biosimilar to Amgen’s Prolia® (denosumab).  The biosimilar is anticipated to launch at the end of 2026 following reimbursemen...

On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was approved in Japan as induction therapy for moderate to severely active Crohn’s disease, where other treatments are ineffective.<...

On 3 September 2026, Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, announced that it has entered into a strategic partnership with China’s Qilu Pharmaceutical for the exclusive licensing and supply in the US of QL2107, biosimilar to MSD’s Keytruda® (pembroliz...

On 2 September 2026, South Korean-headquartered Alteogen announced that it has entered into an option and licence agreement with Novartis for the development and commercialisation of subcutaneous (SC) formulations of Novartis products using Alteogen’s ALT-B4 drug delivery t...