Shots:

• Under the terms of the agreement, Biomm will be responsible to distribute and market biosimilar Pegfilgrastim in Brazil
• The US FDA has accepted the BLA for a proposed biosimilar to reference Neulasta (pegfilgrastim) through a filing using the 351(k) pathway
• Pegfilgrastim is designed to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with CT. The company has developed and commercialized branded and generic formulations, biotechnology products, and APIs in ~ 100 markets in the US, India, South Africa, APAC, LATAM, EU, and the Middle East regions

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