Development of biosimilars is a long and complex process. Timely and thorough analysis of challenges and potential pitfalls is crucial to minimize costs and risks. With five approved biosimilars, Europe serves as a model for other countries looking to define their own regulatory approval criteria. The US is on the brink of passing legislation to establish a statutory pathway for biosimilars approval. However, the opposing interests of biosimilar and innovative companies may result in further delays to the entry of biosimilars.
Datamonitor's Biosimilars Series: Strategic Issues provides in-depth analysis of the biosimilars regulatory environment in Europe and the US and analyzes the challenges biosimilar manufacturers are facing during development.
Scope of this report
- In-depth analysis of factors influencing market uptake of biosimilars
- Analysis of the pricing and reimbursement environment for biosimilars
- Detailed analysis of barriers to entry and strategies for success in the biosimilar market
- Overview of strategies for originators' market share protection
Reasons to Purchase
- Identify key stakeholders that need to be targeted in order to achieve high uptake of biosimilars
- Understand the pricing and reimbursement environment of biosimilars, barriers to entry, and key strategies for success in the biosimilars market
- Gain insight into strategies employed by innovative pharmaceutical and biotechnology companies in order to maintain their market share
Report Highlights
Lack of automatic substitution with biosimilars means that intense promotion strategies need to be employed. Market uptake of biosimilars is highly dependent on acceptance by all key stakeholders especially physicians. All stakeholders need to be informed about biosimilars and various channels can be used.
Payers' reaction to biosimilars is not known, but it is expected they will embrace them after a lag period. Standard incentives which encourage generics use may not be applicable to biosimilars distributed in hospitals, and alternative approaches need to be considered.
Barriers to entry remain high: high development and marketing costs compounded with the need for specialist expertise favor big players with strong financial backing and experience in the branded generics industry. However smaller specialist players are well positioned to enter this market through co-development and co-marketing agreements.
To order or to receive a FREE excerpt of this pharmaceutical marketing special report, Biosimilars Series: Strategic Issues, produced by Datamonitor and distributed by ePharmaceuticals™, a division of HCPro, Inc., call Maureen Croce at 800/639-0515 or e-mail mcroce@hcpro.com. Orders must be paid in full before shipment. All sales are final; no returns or refunds are permitted with this product.
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Datamonitor
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