The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/118943
Biopharm Development & Manufacturing about Phase 3. "So, even though India broadly follows European standards, a product could win approval in one market, but not the other," Nguyen explains. A flexible, creative approach is needed to navigate through the regulatory maze. For Pfizer, this means applying experience with innovator biologics, which was boosted in 2009 by its merger with Wyeth. Newcomers to biologics are partnering to gain expertise, a trend illustrated by the joint venture between Samsung, Quintiles, and Biogen. Knowing what worked in the past will only get a firm so far though. "If there's one thing about biosimilars development I'm comfortable with, it's that it will evolve," Nguyen says. conviction. "We've not progressed far enough to know if a change in European biosimilars' guidance could trigger a shift in Brazil or India, too," Nguyen states. All this uncertainty is a problem for developers of biosimilars. Even at this early stage in the history of biosimilars, some firms have hit development difficulties as regulatory expectations change around them. In October 2012, both Teva, which is developing biosimilars COME PREPARED TO MEETINGS WITH REGULATORS To glimpse into the future, companies must pay attention to the utterances of regulators. Ask the right questions, and a regulator can make the path forward a little clearer. Comment periods on draft guidance documents are an agency's opportunity to listen. But meetings to discuss an individual biosimilar or indication are the best chance to talk over the fine details. At Pfizer, the process of preparing for regulatory meetings begins by looking backwards. "We draw on our knowledge of regulatory precedents, past programs, and known issues with similar products," Nguyen explains. With few biosimilar precedents, the regulatory fate of the innovator biologic being copied is a useful guide. If side effects were a regulatory hurdle for the innovator biologic, a biosimilar will face scrutiny, too. Pfizer feeds knowledge of what happened in the past into its models of biosimilar development pathways. Before meeting with regulators, Nguyen and her team investigate the feasibility of all credible biosimilar development options. The impact of different development choices, such as enrollment targets, is predicted. One pathway might offer the cheapest, fastest route to market but increase the likelihood of regulatory restrictions. Regulatory meetings are particularly useful in markets that are still finalizing the details of their approval pathways. But even in Europe — which was a pioneer in biosimilars — guidance is still evolving. The EMA expects to publish a revised draft of its 2005 guidelines on biosimilars later this year. And, with several emerging markets taking their lead from Europe, the changes could have far-reaching consequences. As with much in biosimilars though, it is too early to say with total experience p partnership nersh ne h p flexib lity ibil y bilit bi Right. e p rtis expertise rtise innovation novati compl c compli nce plianc On Time. transparency ransparency a e c quality qu qual y ualit From DNA to API, we bring leading technical expertise to your project. CMC Biologics is a leading global biologics contract manufacturer, with cGMP compliant facilities in both the United States and Europe. Our innovative team is focused on complete customer satisfaction. CMC Biologics is your manufacturing partner of choice for clinical and commercial products, and services for every stage of your drug development. CMC Biologics CMC Biologics United States Europe +1 425.485.1900 +45 7020 9470 April 2013 cmcbiologics.com LifeScienceLeader.com 37