Innovation and New Product Development Case Study

Biogenerics: Opportunities and Challenges

OR

Abstract:
Back in 1982, the first biotech product, recombinant human insulin hit the market. Hitherto, the biotechnology industry had largely been immune to generic competition with most firms still struggling to turn their ideas into products. The boom in generic pharmaceuticals has not included biotech medicines. The last five years however saw the biotech market growing at a CAGR rate of 27.7%. Patent protection on many biotech drugs is on the verge of expiry. By 2006, 11 biotech drugs worth more than $13 billion in annual sales would face generic competition in America and the EU. However, hurdles remain in the form of the complexity of the biogeneric development process, regulatory barriers and lobbying by patent holding companies.

Pedagogical Objectives:

• To highlight the increasing competition in the biotechnology industry that has largely been immune to generic competition
• To discuss the challenges facing the generic drug manufacturers such as complexity of biogeneric development process, regulatory barriers and lobbying by patent holders.

Keywords : Generics; Biogenerics; Pharmaceuticals; Biotechnology; United States Food and Drug Administration (USFDA); European Medicines Evaluation Agency (EMEA); Innovation Management Case Study; Hatch Waxman Act; Dr. Reddy's Laboratories Limited; Teva Pharmaceuticals; Sicor; Barr Laboratories; Novartis; Patent; Abbreviated new drug application; Exclusivity period

Contents:

• Introduction
• Biogenerics Market: New Horizons
• Firms eyeing Biogenerics
• Regulations
• Challenges