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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.
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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...

On 23 April 2020, the Centre for Biosimilars reported that COVID-19 could speed up biosimilar uptake in the US. Factors which may influence this include widespread unemployment (lack of health insurance to pay for costly originator products), faster adoption of bills that s...

Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.

Significant biosimilar activities this week include

14 April 20 | Mylan and Biocon launched Fulphila® (pegfilgrastim) in Australia. Fulphila® is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and ...

On 16 April 2020, the Centre for Biosimilars published America’s Health Insurance Plans call for further action to address barriers to competition for biosimilars. This action includes shortening product exclusivity periods, creating a searchable Purple Book, introduc...

On 16 April 2020, Biocon announced it had received an Establishment Inspection Report (EIR) from the FDA for two biologics facilities in Bengaluru. Biocon expects that this EIR will allow for the filing of marketing authorisation applications for biosimilar products in seve...