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).

Biosimilars performance below expectations for Biocon : ICICI Direct

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.

Biocon and Viatris receive EC approval for Biosimilar Bevacizumab

The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer

Pharma industry bullish on complex generics and biosimilars

While top industry leaders are optimistic about the growth, they expect the special incentives and regulatory streamlining from the government’s side

Unichem Laboratories receives ANDA approval for Apremilast Tablets

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member

Biocon Biologics to offer its oncology biosimilars in 30+ countries

The partnership is a significant step in delivering advanced cancer therapies to patients.

Slow recovery in biosimilars for Biocon: ICICI Securities

Dr Christiane Hamacher, has stepped down as the MD of Biocon Biologics and will be succeeded by Dr Arun Chandavarkar.

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke

Fitch upgrades Biocon Biologics outlook to positive, affirms ‘BB-’ rating