Taren Grom, Editor
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3 PharmaVOICE J un e 2003 PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh DIRECTOR OF SALES Darlene Kwiatkowski MANAGING EDITOR Denise Myshko CONTRIBUTING EDITORS Elisabeth Pena Kim Ribbink Lynda Sears Copyright 2003 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. Volume Three, Number Six PharmaVOICE is published 12 times per year by PharmaLinx LLC, P.O. Box 327, Titusville, NJ 08560. Postmaster: Send address changes to PharmaVOICE, P.O. Box 327, Titusville, NJ 08560. PharmaVOICE Coverage and Distribution: Domestic subscriptions are available at $160 for one year (12 issues). Foreign subscriptions: 12 issues US$330. Contact PharmaVOICE at P.O. Box 327, Titusville, NJ 08560. Call us at 609.730.0196 or FAX your order to 609.730.0197. Contributions: PharmaVOICE is not responsible for unsolicited contributions of any type. 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Number 6 Send your letters to feedback@pharma voice.com. Please include your name, title, company, and business phone number. Let ters chosen for publication may be edited for length and clarity. All submissions become the property of PharmaLinx LLC. Letters Pharmaceutical and particularly biotech nology companies must find ways to exploit opportunities in this attractive market as growth from other revenue streams slows. Compounding this trend is the threat of widespread biogeneric competition, which industry experts predict will become a reali ty by 2010. Thus, companies must aggres sively protect patents and develop reformula tions to remain competitive. The therapeutic proteins market is becoming increasingly attractive to generic competitors, which pose a significant threat to the revenue streams of some of the more established classes. According to Datamoni tor analysts, there are a number of drivers for the introduction of generic competition. Firstly, the market potential for biogenerics is sizable, with more than half of the 2001 ther apeutic protein market being susceptible to generic erosion of market share by the end of 2005. Secondly, because of the high prices of therapeutic protein products, any cost savings to the payer, regardless of how small, could be a significant driving force. Consequently, many generics manufacturers are beginning to make strategic moves within this area. There are high barriers to entry, however, and this will result in companies that develop biogenerics making considerable investments to gain access to the market. These include the high cost of manufacturing biologic products, the expense of gaining regulatory approval for this new class of products, and the investment required to reassure the medical community of the safety of the products. In addition, generic companies can expect to come up against considerable opposition from pharmaceutical companies with brand ed biologic products, adding numerous court cases to the hurdles that must be negotiated. The absence of an approval pathway for generic biologic products is the only legiti mate barrier to the introduction of generic competition. The highmarket potential for biogeneric products, coupled with the signif icant cost savings experienced by healthcare payers, will ensure that within the next 10 years, a legal pathway will be established. “While it is of interest to contemplate the concept of generic biologics, I believe there are a number of issues that need to be addressed before one can really say that a biologic manufactured by one process in one facility is equivalent to the same biologic manufactured by a different process in a dif ferent facility,” says Christopher J. Searcy, Pharm.D., VP of corporate development at Nektar Therapeutics. “Until a track record has been established, demonstration of effi cacy and safety will still be the norm rather than the exception for biologics.” The Biotechnology Industry Organiza tion (BIO) has made public its position that the approval of followon biotechnology products, biogenerics, must be based on the same rigorous standards applied by the Food and Drug Administration (FDA) for the approval of pioneer biotechnology prod ucts. According to BIO, the science does not exist to provide an alternative to a full complement of data, including clinical evi dence, to demonstrate safety and effective ness for followon biotechnology products. “Even if a generic company does submit a complete filing, it hasn’t shown that the product is the same,” says Gillian R. Wool lett, MA, D.Phil., VP of science and regu latory affairs at BIO. “All that it has shown is that what was submitted has purity, potency, identity, and/or is safe and effec tive for the use for which it is proposed. But it doesn’t show that the two products are substitutable.” Taren Grom Editor While it is of interest to contemplate the concept of generic biologics, there are a number of issues that need to be addressed. T