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Significant biosimilar activities this week include

23 April 2020 | Henlius Biotech announced it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.
28 April 2020 | Mylan and Biocon launched Fulphila® (pegfilgrastim) in Canada. Ful...

Teva and Celltrion announce the launch of Truxima® in the US. Truxima® is indicated for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis and miscroscopic polyangiitis, making it the only approved biosimilar with the same indications as Rituxan®.

AbbVie released its Q1 2020 financial results, reporting a 13.7% increase in US sales of Humira® from Q1 2019. In global markets, Humira® sales were down 14.9%, a decline that was attributed to biosimilar competition.

Amgen filed suit against Hospira and Pfizer, alleging infringement of US patent 10,577,392, relating to the manufacture of Neupogen®. Interestingly, the patent was only granted on March 03, 2020, nearly 2 years after Hospira launched Nivestym®.

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of a potential recombinant adenovirus vaccine.

Gedeon Richter announces it has entered an asset purchase agreement with Mycenax Biotech for the purchase of a biosimilar tocilizumab product. Under the agreement, Richter will receive worldwide rights to develop, manufacture and commercialise the product which is expected ...

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Canada. Fulphila® is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Significant biosimilar activities this week include

21 Apr 20 | The Centre for Biosimilars reported that Xbrane Pharma was continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.
23...

J&J announces it has filed two supplemental marketing applications for Simponi Aria (golimumab) with the FDA. J&J have applied for the additional indications of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients at least two yea...

On 23 April 2020, a presentation at the American Academy of Managed Care Pharmacy eLearning Days discussed future biosimilar launches in the US. A particular emphasis was placed on the number of adalimumab biosimilars waiting to come to market, with competition in this spac...