Generate new revenue streams by seeking orphan designation of the reference brand in a rare disease, allowing for label extension in a competition-free indication with a period of market exclusivity.
(Co-)Development of more-advanced biologics offering an advantage over the brand originator molecule and biosimilars to stifle competition. Next-generation biologics must offer significant benefits in terms of efficacy, safety and / or compliance to supersede the originator brand and generate sufficient revenue to counteract the associated costs.
Discourage market competition by defending the patent portfolios in place for the branded biologic; “evergreening” of exclusivity periods may be used strategically to delay biosimilar entry and fend off imminent competition.
Design biosimilars around, challenge, or license key patents for the reference brand. Employ development strategies that facilitate navigation of country-specific regulatory procedures.
Acquisitions and partnerships with other pharmaceutical companies and CROs / CMOs complement development capabilities, share costs, facilitate access to a broader range of geographies, and bridge knowledge gaps in the development and marketing of biosimilars.
Offer price discounts compared with the reference brand, facilitating patient treatment access and alleviating the economic burden to healthcare systems.
Exclude competition from a lower-priced biosimilar by founding exclusive agreements with payers in the form of rebates and price discounts. Originator brand manufacturers may also secure sales revenue via brand price hikes ahead of biosimilar launch.
Strategies highlight the cost-saving benefits of biosimilars to payers, ease any prescriber and clinical stakeholder group concerns regarding clinical attributes of biosimilars, and educate patients in order to create a more receptive market environment.