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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.

UK Competition and Markets Authority closes investigation into MSD discount scheme after finding no grounds for further action. This decision is contrary to the provisional findings in May 2017 which indicated a breach of competition law.

Alvotech commences Phase III trial of 100mg/mL adalimumab biosimilar. 400 participants will be enrolled across 30 sites in Europe in this comparability study.