Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
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.
The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
While top industry leaders are optimistic about the growth, they expect the special incentives and regulatory streamlining from the government’s side
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .
The centralized marketing authorization granted by the EC is valid in all EU Member
The partnership is a significant step in delivering advanced cancer therapies to patients.
Dr Christiane Hamacher, has stepped down as the MD of Biocon Biologics and will be succeeded by Dr Arun Chandavarkar.
A nationwide network of over 1,000 accredited clinical trial sites will be created to accelerate drug development timelines and enhance research credibility
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