The much-anticipated draft guidance on biosimilars product development issued by US Food and Drug Administration (FDA) gives a direction to biosimilars developers targeting the US market. The FDA has issued three draft guidance documents to assist the industry in developing biosimilars products in the US. According to this new pathway, biological products will be approved on demonstrating that they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA.

When it comes to getting new biosimilars products to the market, the FDA has taken an innovative approach to support their development at every step of the process. "These draft documents are designed to help the industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower costs for consumers," commented Dr Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, during the announcement of the guidelines.

These regulatory guidelines will also help Asian biosimilars developers to enter the US market. So far, the biggest challenge for Asian players that have high dominance in generics drugs in Asia, is the absence of clearly defined regulations in different countries to develop biosimilars. They have limited close interactions with regulatory agencies, which is very critical for a successful biosimilar application. With the clarity coming from the US, the Asian players will now get a chance to develop generic drugs for the vast market of the US, supplying cheaper versions of highly crucial drugs.

Asia already has many companies such as Cipla, Dr Reddy's Laboratories, Biocon, Wockhardt, Samsung, LG Life Sciences, Celltrion, SK Chemicals, Simcere and ScinoPharm that have proved their capabilities and competitiveness in developing and commercializing biosimilars for the Asia market.

Reacting to the developments, Mr Cecil Nick, vice president, Technical, Parexel Consulting, says, "There is no defined guidelines and requirements for all biosimilars products and in cases where they exist, there is no guarantee that they will not change."