PM360 - October 2010 - Biosimilars New Game For Innovators And Imitators


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PM360 - October 2010 - Biosimilars New Game For Innovators And Imitators

  1. 1. GUEST COMMENTARY Gil Bashe is Etecutive Vice President of Makovslzy 4 Company. He is counselor to phnmm, biotech, and medical device manufacturers and patient advocacy groups. Contact him at gl>ashe@mahovshy. com 8 pmaso ocroaea 20:0 BIOSIMILARS—NEW GAME FOR INNOVATORS AND IMITATORS BY CIL BASHE Biotech marketers pay heed, the “new normal" requires a new set of skills to meet the ever-changing environment. With the Patient Protection and Affordable Care Act of 2010, there is Congressional blessing to bring to market biosimilars, also called follow—on biologics. However, seven months into the legislation passage, the FDA has yet to provide formal guidance on the filing process. Will this leave biotech blockbusters on the market 12 years or longer suddenly vulnerable to competition from wanna—be biosimilars? Adding to the regulatory confusion, many biotech products were approved as new drug applications (NDAS) long before the Center for Biologics Evaluation 69: Research (CBER) Therapeutic Biologic Applications (BLA) process was instituted. These biologic—like aNDA (abbreviated NDA) products slipped through the CBER net without clinical validation, yet still need to shoulder a burden of efficacy and safety proof. Make no mistake; biosimilars are not “large-molecule” generic drugs. While similar in aspiration, they remain complex molecules, often injectables, and expensive to manufacture. Do not expect generic companies to readily enter the competitive biosimilar fray. Going forward, this leaves tough choices for those trying to navigate early market entrance. Companies such as Merck, Pfizer, Teva, and Hospira declaring biosimilars to be part of their economic future must now determine whether to develop products as if they are new biologics—performing time-intensive and expensive clinical trials and filing BLAs—or move forward on the potentially shorter, biosimilars route. clinical confidence Determines Success According to the Biosimilars Advisory Service: Acceptance of Biosimilars Across Physician Specialties, 33% of surveyed U. S. physicians would feel comfortable pre— scribing biosimilars that launched with only one Phase III study as supporting evidence, compared with an average 20% in France and Germany. The same survey found when considering manufacturers of biosimflars, U. S. and European physicians both place the most trust in biotech companies experienced in manufacturing biologics. It’s not surprising then that it is the larger, more experienced companies—like those noted previously- that have already staked their reputations in the game. Why the surprise entrance of pharma brand powerhouses into What many will consider a new phase of generic medicines? Biosimilars are not generics. A Science-Based Marketing Marathon Too often, marketers assume that biosimilar competition means immediate generic—like share erosion. That will not be the case in this new biotech terrain. Gaining biosimilar market share will mean more than just lower pricing to attract payers. In fact, costly regulatory, clinical, and manufacturing investments mean biosimilars will be priced only 20% lower than the innovator products. Consider the post—launch costs for in—home use patient training, 24/7 call—in support, and physician education. The type of product support and investment required to introduce a biosimilar into the market is best suited to big biopharma. While the FDA will begin to address in a November meeting safety parameters for biosimilars, category leaders should first assess the patient—care complexities of their biotech products before assuming the current blockbuster should be shipped to the nonpromoted unit. Brands and biosimilars will both need strong marketing support, and advertising dollars will not disappear but rather shift to digital communications, advocacy, education, ongoing research, and scientific exchange. Generic drugs will no longer just be pushed on the market to fend for themselves. Those who do not anticipate and adapt to these shifts will be left playing the new game under the old rules. 0 DISCLAIMER: The Guest Commentary page allows contributors to voice their opinions on important issues that affect the indusny. The views of the authors are their own and are not necmarily those ofPl/ L360 and its staff