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Latest From Roche

Biocon-Mylan's Plans For Broader US Fulphila Access, Glargine On Track

Biocon-Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.

Commercial Biosimilars

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Approvals Drug Review

New CEO Brett Monia Takes The Lead As Ionis Prioritizes Non-Partnered Programs

Monia told Scrip at the J.P. Morgan Healthcare Conference that the company will be more selective about partnerships going forward and build commercial capabilities to market Ionis-owned drugs.

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