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Sandoz announced that the EMA has accepted its application for high concentration (100mg/mL) citrate-free product Hyrimoz® (biosimilar adalimumab).  Sandoz’s application seeks approval for all AbbVie Humira® indications.

Alvotech announced that its shares and warrants began trading on the Nasdaq on 16 June under the new ticker symbols ‘ALVO’ and ‘ALVOW’ respectively, following the completion of the company’s business combination with Oaktree Acquisition Corp. II.  The transaction was suppor...

Innovent Biologics and PT Etana Biotechnologies announced that the Indonesian Food and Drugs Authority has approved Bevagen® (bevacizumab biosimilar) for metastatic colorectal cancer (mCRC); locally recurrent or metastatic triple negative breast cancer (mTNBC); advanced, me...

MSD announced that the FDA has accepted its sBLA for Keytruda® (pembrolizumab) as adjuvant therapy for stage IB-IIA non-small cell lung cancer following complete surgical resection.

Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).  Under the agreement, Organon has exclusive global commercialisation rights “except for ...

Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology Association 2022, reporting that SB12 is bioequivalent to Alexion’s Soliris®.

Alvotech announced the launch of Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) in Europe by its partner STADA.  The initial launch regions include France, Germany, Finland, and Sweden, with further launches scheduled “over the coming months”.  Whilst Hukyndra® is ...