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Fresenius Kabi announced that the EMA has accepted its MAA for MSB11456 (biosimilar tocilizumab).  The application includes clinical data for both subcutaneous and IV administrations.

Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical canc...

Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima™ (biosimilar adalimumab).  The Hadlima 50mg/ml formulation was FDA approved in July 2019.  Hadlima is expected to be launched on or after 1...

Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to Janssen’s Stelara in a Ph III clinical trial in plaque psoriasis patients.  Formycon’s extended pharmacokinetics Ph I study has commenced.  This follows Formycon’...

MSD and Orna Therapeutics announced that they have entered into a collaboration agreement to discover, develop and commercialise multiple RNA programs, including vaccines and therapeutics in the areas of infectious diseases and oncology.

MSD’s PD-1 receptor blocker Keytruda is approved in the US and Europe for the treatment of a range of tumours, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin Lymphoma, urothelial carcinoma, oesophageal cancer, cervical ...

Significant biosimilar activities this week include:

27 Jul 22 | CN | Ph III trial shows Qila’s denosumab biosimilar improves bone mineral density

It has been reported that a Ph III clinical trial of Qilu Pharmaceutical’s biosimilar denosumab, QL1206, showed b...

Opthea announced a non-dilutive financing transaction for up to US$170 million from investment funds working with Launch Therapeutics to finance and advance the ongoing Ph III clinical trials and pre-commercialisation activities of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) for w...

Alvotech announced that its Board of Directors has approved to move its share listing from the First North Growth Market to the Nasdaq Main Market in Iceland.

Alvotech became the first dual US-Icelandic listed company on 23 June 2022.

Alvotech, Mylan, the Association for Accessible Medicines, and 42 professors of law, economics, business and medicine filed amicus curiae briefs in the US Supreme Court in support of Teva’s petition for a writ of certiorari.  Teva is seeking review of the controversial divi...