Reliance GeneMedix PLC
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Latest From Reliance GeneMedix PLC
Biosimilars: A New Kind Of Innovation
The lesson from first-generation biosimilars is that these aren't just small-molecule style copies. They require significant clinical and commercial support to overcome prescriber skepticism. For those lining up to tap into the next-generation opportunity, biosimilars represent a new kind of innovation, where the novelty lies in a drug's value-focused pricing, quality, cost-effective production, and in peripherals such as support-services and means of delivery. Although biosimilar market dynamics will vary from molecule to molecule, this emphasis on price and value rather than scientific breakthrough exemplifies a new definition of innovation in the biopharma sector.
Biosimilars: EMEA Wants Approvals
European regulators’ guidelines on biosimilars show that they are serious about quickly approving cheaper follow-on biologics. The hurdles may come thereafter.
Trade Sales Trump IPOs, Even for Platforms
Europe's summertime flurry of private biotech sell-offs points to growing pragmatism among management and VCs, and still-poor valuations on the public markets. Firms which haven't already considered the trade sale opportunity should do so--even early-stage, pre-product platform groups.
FDA Hesitates on Biogenerics
A long-awaited Food and Drug Administration (FDA) workshop held in mid-September, highlighted just how far the agency is from establishing a regulatory path for generic copies of biologics. Although it yielded few surprises, the meeting provided a concentrated public forum for interested parties to present in-depth views of all sides of the issue--an unusual event in itself
Company Information
- Industry
- Biotechnology
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Pharmaceuticals
- Generic Drugs
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