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Formycon announces its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, which Formycon and Bioeq expect will simplify the approval procedure.

Pharma Intelligence announced the Global Generics & Biosimilars Digital Awards Winners. Alvogen, Accord Healthcare, Aurobindo, STADA, Dr Reddy’s Laboratories, Samsung Bioepis, and Richard Saynor of Sandoz were among the winners.

The Australian Government announced it has secured an additional 50 million potential COVID-19 vaccine doses through agreements with Novavax and Pfizer/BioNTech.

Alvotech announces it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be r...

Alvotech announced it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be r...

Medicines for Europe released a white paper which reviews the barriers to generic and biosimilar market entry. In particular, the unlimited number of divisional patents which can be filed in the EU, product hopping and anticompetitive rebates were identified as significant ...

Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).

Hindu Business Line reported Strides Pharma has filed a submission with the EMA for PTH® (proposed teriparatide biosimilar).

SBS News reported Federal Health Minister Greg Hunt announced the Government is close to securing two supply contracts for an additional two proposed COVID-19 vaccines. Additionally, Minister Hunt announced that PM Scott Morrison will present a plan for vaccine rollout to N...

Significant biosimilar activities this week include
22 Oct 20 | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced recruiting in Poland.

26 Oct 20 | Samsung Bioepis announced results from two post-market...