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Bio-Thera Solutions announced that China’s NMPA has approved BAT1806 (biosimilar tocilizumab) for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

STADA and Xbrane announced that Ximluci® (ranibizumab, biosimilar to Roche/Genentech’s Actemra®) has been granted marketing authorisation by the MHRA. Under a July 2018 agreement, STADA and Xbrane are jointly responsible for development and manufacturing of Ximluci, while S...

Alvotech and Fuji Pharma announced an expansion to their existing exclusive commercialisation partnership in Japan, adding a new undisclosed biosimilar candidate.  The commercialisation agreement, which was first announced in 2018 and was most recently expanded in February ...

Alvotech announced the initiation of a pharmacokinetic study for AVT05 (biosimilar golimumab candidate to Janssen’s Simponi® and Simponi Aria®).  Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April...

MSD announced that it has completed the cash tender offer for all of the outstanding shares of common stock of Imago BioSciences, Inc for $36 per share. Merck intends to complete the acquisition of Imago through a merger of MSD’s wholly owned subsidiary and the common...

Luye Pharma announced that its subsidiary Boan Biotech has signed an agreement with CP Pharmaceutical Qingdao Co., Ltd. (CP Qingdao) to grant CP Qingdao the right to commercialise Boyoubei® (biosimilar denosumab) in mainland China.  Boyoubei was approved by China’s NMPA in ...

Significant biosimilar activities this week include:

07 Jan 23 | Biocon receives complete response letter over insulin-r product.

Biocon announced that it has received a complete response letter (CRL) from the FDA in relation to its insulin-r product.  Biocon ...

Rani Therapeutics announced that it has partnered with Celltrion for the development of RT-111 (orally administered ustekinumab biosimilar).  Under the agreement, Celltrion will exclusively supply drug substance CT-P43 (biosimilar ustekinumab drug substance) to Rani.  Rani ...

Coherus Biosciences announced that it has executed a binding term sheet with Klinge Biopharma granting Coherus the exclusive US commercialisation rights to Klinge’s FYB203 (biosimilar aflibercept, targeting Bayer’s Eylea®, developed by Regeneron).  Coherus expects to comple...