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On February 16,
Leerink Swann's Global Healthcare Conference 2012 featured two presentations and several more private discussions featuring Center for Drug Evaluation and Research ("CDER" Director Janet Woodcock, M.D., as well as her colleagues, Steven Kozlowski, M.D., CDER's Director of Office of Biotechnology Products, and Keith Own Webber, Ph.D., CDER's Deputy Director, Office of Pharmaceutical Science, Acting Director, Office of Generic Drugs. The trio presented a discussion "Biosimilars Take the Stage" followed by Woodcock's Keynote Address on "New Trends in Drug Regulation and Innovation", and several smaller question-and-answer-format meetings regarding these topics and more. This is part one of a two-part series and concerns the biosimilars presentations. Part two will be posted on Tuesday.
Leerink's biosimilars session was moderated by Joshua Schimmer, M.D. and Jason Gerberg, J.D./M.B.A. with co-moderators Seamus Fernandez and Joseph Schwartz. Kozlowski provided some preliminary remarks followed by a question-and-answer format by the moderators. Kozlowski explained that the purpose of FDA's first set of biosimilars guidances, which we initially reported on
here, was to set the scientific framework for approaching biosimilar product development and provide some interpretations of the new statutory terminology. Kozlowski explained that FDA decided to take a "totality of the evidence" and "stepwise approach", where the structural similarity of the biosimilar, as demonstrated by the sponsor, drives the development of the clinical program to support approval.
Woodock added that FDA has had a challenge to retrain their reviewers to think of biosimilar review as an "inverted pyramid." Typical drug review includes pre-clinical studies followed by increasingly large clinical studies, culminating in pivotal, larger-scale studies to demonstrate the safety and efficacy of the product that become the focus of the approval, i.e., the regular pyramid (pre-clinical on top, phase III clinical trials on the bottom . In contrast, biosimilar product development is envisioned to be characterized as spending a bulk of the resources up front, characterizing the innovator's product and the biosimilar (i.e., the top of the pyramid to lead to smaller clinical studies to demonstrate similarity or test for immunogenicity or other elements that require testing, not duplicating the safety and efficacy testing that was already conducted by the innovator.
AstraZeneca has unveiled its "first-ever direct-to-patient programme", which will see the Anglo-Swedish drugmaker offer its breast cancer drug Arimidex to US patients for $40 a month.
Under the scheme, patients with a valid prescription for Arimidex (anastrozole or a generic of the aromatase inhibitor (it went off-patent in the USA in the middle of 2010 can have the branded version delivered directly to their home by pharmacy benefit management company Express Scripts. AstraZeneca says that "calls from patients seeking information on how to obtain the brand Arimidex more affordably helped spur creation of the direct-to-patient programme".
The company adds that upon further research, it felt that eligible patients could realise "significant cost savings through Arimidex Direct". However, AstraZeneca notes that "prescription insurance coverage, including Medicare and Medicaid, cannot be used for any type of reimbursement", so the scheme only applies to patients who pay out of their own pockets.
At $40 a month, the price is above the normal $10 co-payment for generic anastrozole, but well below what insured patients could pay for the branded version - the price of 30 tablets of Arimidex at drugstore.com is listed at $458.97.
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