Indian multinational pharmaceutical company Lupin Ltd (Lupin) has signed an agreement with Brazilian firm Biomm SA to distribute and market a pegfilgrastim biosimilar in Brazil. In related news, Indian firm Gland Pharma has announced plans to enter the market for biosimilar manufacturing.
On 3 December 2021, Lupin announced an exclusive distribution and marketing agreement with Biomm SA, a biotechnology company headquartered in Brazil. Under the agreement, Biomm will distribute and market Lupin’s pegfilgrastim biosimilar in Brazil.
Pegfilgrastim is a form of filgrastim, a recombinant human granulocyte colony-stimulating factor (G-CSF) analogue, with a significantly longer half-life. Pegfilgrastim stimulates the production of neutrophils and can be used to prevent infection in patients with reduced neutrophil count, such as those receiving chemotherapy. It is sold under the brand name Neulasta by originator company Amgen.
The US Food and Drug Administration (FDA) accepted Lupin’s Biologics License Application (BLA) for the pegfilgrastim biosimilar in June 2021 [1], Lupin’s first biosimilar application to be filed in the US.
Another Indian pharmaceutical company, Gland Pharma, has announced near-term plans to expand into complex injectables, contract development and manufacturing biosimilars. Gland Pharma says it has made ‘good progress’ in R & D for complex injectables and plans to make four complex injectable filings this financial year.
‘Our near-term focus remains on establishing a strong portfolio of complex injectables for which while we are having an internal program, we are also looking at acquisition opportunities to help expedite the development process,’ said MD and CEO Srinivas Sadu.
In terms of biosimilars, biosimilar contract development and manufacturing is the next long-term growth driver for the company. ‘While the experience in vaccine collaboration has helped us gain the know-how and accelerated creating facility and technical team, we are also looking at opportunities to collaborate on the biosimilar front to build a pathway to cement our position in the future’, Mr Sadu elaborated.
The company already has a 60 KL capacity for biosimilars, which was created for the COVID-19 vaccine and can be expanded for biosimilar manufacturing.
‘[We] are talking to companies within the Fosun framework and trying to start up with them to initially launch some of their substances from the Indian site’, Mr Sadu added. The company is also keen to get in touch with other generic and innovator companies that want to create a biosimilar portfolio.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Lupin’s pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 11]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-lupin-s-pegfilgrastim-biosimilar
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