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Genentech files complaint against Pfizer in the District Court of Delaware alleging infringement of 22 patents and requesting a declaratory judgment of infringement of several of these patents.

Fresenius Kabi announces European Commission approval of biosimilar adalimumab, Idacio® for all indications. 

Sandoz announces resubmission of its BLA for pegfilgrastim biosimilar candidate, including new data from pharmacokinetics and pharmacodynamics studies.

The Mayor and City Council of Baltimore files additional class action against AbbVie, alleging that anti-competitive behaviour prevented the introduction of biosimilars and allowed AbbVie to demand ‘supra competitive prices’. Additionally, the complaint alleges ...

Celltrion announces completion of recruitment for Phase III clinical trials of biosimilar adalimumab.

Lupin announces approval of biosimilar etanercept in Japan for the treatment of moderate to severe Rheumatoid Arthritis. 

UFCW Local 1500 Welfare Fund, a grocery union, files class action against AbbVie, Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer and Momenta, alleging misconduct and antitrust violations. The union alleges that the hundreds of patents which protect Humira® an...

Sagent Pharmaceuticals announces acquisition of manufacturing site in North Carolina providing Sagent with the potential to produce both small molecule and biologic products. This is the first FDA approved facility in the Nichi-Iko Group.

PBAC Committee recommends all 4 brands of Celltrion biosimilar products (Tuxella®, Rituzena®, Ritemvia®, Truxima) for PBS listing in AU for all TGA registered indications for which the reference brand Mabthera is currently listed on the PBS, despite approved skinny label). ...

Roche announces EC approval for a label expansion of MabThera®. The approval now includes the treatment of pemphigus vulgaris, the first major advancement for the treatment of this disease in more than 60 years.