skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration

The enactment of the US FDA Biosimilar 351(k) pathway in March 2010 has created uncertainty on many fronts. The innovator, biosimilar developer, FDA, and payer have spent years readjusting their strategies to prepare for the introduction of biosimilars in the US. Biomedtracker’s recent Biosimilars Special Report characterizes the biosimilar environment through a discussion of biosimilar development, regulatory pathways, reimbursement, and an analysis of US partnerships deals.


On the regulatory front, the Report begins by providing an evaluation of relevant analytical techniques that reveal structural variability between a biosimilar and its reference product. The US regulatory pathways to approval are then outlined and discussed as industry awaits FDA guidance regarding the “Interchangeable” designation. This designation is unique to the US and would bridge the gap between biosimilars and their generic cousins. The Biosimilar Special Report follows with a data driven discussion of the development timeline of biosimilars vs. standard biologics. Data has shown that the biosimilar 351(k) pathway does in fact offer an expedited pathway to approval through the reduction of Phase I and Phase III requirements, and forgone Phase II studies. Biomedtracker estimates a difference of 3.37 years for Phase I to Phase III development between biosimilars and standard biologics.


The Biosimilars Special Report also delves into the partnering landscape by analyzing its primary observation of deals concerning US biosimilars. Results first show that partnerships for US biosimilars were predominantly initiated during US preclinical development (56%), which confirms the advantage of early partnerships for biosimilar development. By partnering at the discovery phase, large cap companies can use their resources to focus on marketing, while small cap and foreign companies can focus on the discovery of biosimilars, thereby leveraging each company’s individual strengths. Of the seven biosimilars partnerships that began prior to US development, all have progressed to Phase III or an approval filing to the FDA. Not only can ex-US data build a stronger case for approval, but US companies can also utilize the experience of emerging market companies that are familiar with biosimilar development. It is therefore advantageous for companies to partner early in the US or while development is ex-US.


On the payer side, one-on-one interviews with reimbursement experts and industry research have revealed that payers are highly receptive to the introduction of biosimilars. Payers anticipate price and rebate discussions from the biosimilar for formulary inclusion and from the brand to maintain formulary access. One KOL interview suggested that price reduction of at least 20%, including rebates, would be required to make the formulary disruption worthwhile. Upon agreement, payers are prepared to use formulary management tools like tiering, step-therapy, and prior authorization to encourage the uptake of biosimilars.


For the complete report, visit BioMedTracker.

Read also

  • Biomedtracker: follow the drug development process

    Accurate, Intuitive and Updated In Real Time

    03 Apr 2017

    Learn why pharmaceutical, biotech, and investment companies rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication.

  • Biomedtracker: follow the drug development process

    Biomedtracker 2018 Early Outlook Report

    What's on the horizon for pharma in 2018? Find out with Biomedtracker&rsquo;s Early 2018 Outlook Report extract. Download free extracts from this essential report, which investigates the catalysts expected to occur in the first part of the year for 21 different drugs.<br />

    Topics Drug development landscape

  • Scrip: industry news and insights

    Bayer Bets On Oncology Pipeline Vows To Increase 2017 R&D Budget

    By Lucie Ellis 22 Feb 2017

    Bayer has launched an internal oncology R&amp;D unit to speed up development of its pipeline cancer therapies and ensure the company is first to market with its late-stage treatment candidates, head of pharma Dieter Weinand told Scrip on the sidelines of the pharma's annual results conference.

    Topics Cancer


Next steps

Getting a demo tailored to your needs is the best way to see how our solutions will help you gain an advantage.

Request live demo now:

Our team is always happy to hear from you. Please call us at:

  • US Toll-Free  : +1 888 670 8900
  • US Toll           : +1 908 547 2200
  • UK & Europe : +44 (20) 337 73737
  • Australia        : +61 2 8705 6907
  • Japan              : +81 3 6273 4260

Or please submit your inquiry via the form so that we can provide you the best possible customer service.

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now: