This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
Despite nearly 20 years of availability, biosimilars show worldwide adoption rate of only 14% in initiative-tracked countries, while reference medicines still represent 86% of biologic
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio
To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan
The proposed transaction involves the sale of the global biosimilars portfolio of Viatris to Biocon Biologics
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
The progress has been encouraging with approvals and launches in the US, EU, Japan, Australia and Emerging Markets. Post Mylan Upjohn (Pfizer) merger, the scope has been extended to China as well.
While top industry leaders are optimistic about the growth, they expect the special incentives and regulatory streamlining from the government’s side
The partnership is a significant step in delivering advanced cancer therapies to patients.
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