FDA approves Omnitrope, the follow-on biologic; Sandoz, FDA disagree on implications for other biosimilars; PAT played a role

 HGH photo Stop the presses! The FDA has just approved Novartis' human growth hormone "biosimilar," Omnitrope. Here's Sandoz' version of the news: The US Food and Drug Administration has granted approval for the company’s recombinant human growth hormone, Omnitrope®, as the first follow-on version of a previously approved recombinant biotechnology drug in the US. Omnitrope was approved in the US using the so-called 505(b)(2) pathway of the Hatch-Waxman Act, becoming the first recombinant copy of a biotech drug to be approved by this manner... “The FDA’s approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide,” said Dr. Andreas Rummelt, CEO of Sandoz. “The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the US.” The FDA’s decision follows the approval of Omnitrope on April 19 by the European Commission. Omnitrope is now on the market in Germany, with launches planned for additional countries in Europe later this year. Omnitrope is also available in Australia, where it was launched in November 2005. Sandoz believes that rigorous scientific criteria should be consistently applied to the approval process for all follow-on biotechnology medicines. However, the unnecessary or unethical duplication of animal studies and human clinical trials should be avoided so that resources are not wasted that could otherwise be invested in innovation and continuous improvement. Sandoz also believes that these types of medicines should be approved and produced once patents have expired without specific reference to the trade secrets and confidential commercial information of innovators. Biotechnology medicines are produced in living organisms altered by recombinant technology, and being proteins, are larger than smaller pharmaceutical molecules produced by organic synthesis. However, using advanced product development, analytical methodologies and manufacturing processes, companies like Sandoz can manufacture high quality medicines and bring them to market with savings for patients and payors. As more recombinant biotechnology medicines lose protection in the coming years, these products are expected to play a key role in the growth strategy of Sandoz. For its part, FDA insists that the approval will not open the floodgates for other "follow on" biologics. Regardless of FDA's careful wording, the approval of any follow on biologic is big news and signals a change in the U.S. regulatory mindset. As you read Sandoz' release, you may hear the voice of Ajaz Hussain (Sandoz' VP of drug development) in the paragraphs where "analytical technologies" and "modern manufacturing" are mentioned. The approval may also set a precedent for the increased use of process analytical technologies (PAT) in biopharm, and attract other developers of biogenerics and "follow ons" to the PAT framework. -AMS