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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...

Mylan filed a petition for inter partes review of Regeneron’s US 10,130,681 and US 10,888,601, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the ‘681 and ‘601 patents...

Biocon announced that its subsidiary Biocon Biologics has received a complete response letter (CRL) from the FDA in relation to its insulin-r product.  Biocon reported that the CRL cites additional data required and that it is in the process of addressing the CRL.

Samsung Bioepis filed a petition for inter partes review of Regeneron’s US10,130,681, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the ‘681 patent.

Alvotech and Teva announced that the FDA has accepted for review a BLA for AVT04 (biosimilar ustekinumab). Alvotech reported that it expects the review to be completed in the second half of 2023.  AVT04 is being developed under a strategic agreement between Alvotech and Tev...