Earlier this year, in Feb. 2012, FDA issued draft guidance on biosimilar product development, and The Patient Protection and Affordable Care Act, which was signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway — under section 351(k) — for biological products that are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product.
Generally, biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials. A biosimilar is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency. Through this new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product.
Recently, the Indian Government launched its biosimilars guidelines in Boston at the BIO industry conference on June 19. The guidelines are aimed at providing a “clear” regulatory pathway for manufacturers of biologic similars and will be applied to new filings now. So far, India has approved over 20 similar biologics that include recombinant therapeutics, monoclonal antibodies based on abridged regulatory requirements.
As per the latest guidelines, the manufacturers must prove similarity to a reference product, i.e. either an innovator drug licensed in India or approved elsewhere along with a requirement of 4 years post-market safety data. Under present circumstances, these guidelines seem to be clearly aimed at encouraging more investment in biosimilars in India, both by domestic and foreign companies.
As per the guidelines, India’s definition of similar biologic includes: a biological product or drug produced by genetic engineering techniques and claimed to be “similar” in terms of quality, safety, efficacy to a reference innovator product, which has been granted a marketing authorization in India by a competent authority on the basis of a complete dossier, and with a history of safe use in India.
From the perspective of a pharmaceutical patent attorney, these guidelines on biosimilars may prompt companies to be diligent while deciding what to keep as a trade secret and how to follow a successful IP strategy for patenting their products. Additionally, for companies interesting in developing biosimilars, Intellectual Property will be an even bigger issue, as for such products, the innovations and most of the R & D relates to improvements, which may be rejected by the patent office for protection by means of patents.
A recent market study reveals that approx. twelve compounds of biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2012. This is mainly due to the fact that the expiration of patents and other intellectual property rights for originator biologicals over the next decade opens up opportunities for biosimilars to enter the market and increase industry competition.
Consequently, this will result in an increased practice of protecting improved innovations by way of trade secrets. Although, in recent past, many pharmaceutical companies haven’t focused on trade secrets, but these have been used by biotech companies regularly, particularly for manufacturing processes, which often are crucial to a new drug’s success. In most countries, manufacturing processes are patentable, but at the same time they require full disclosure of all information regarding enablement of the invention, which subsequently discloses such details to the competitors for possible design around without infringing any patent.
In stark contrast, trade secrets, allow a company to keep manufacturing processes away from the reach of competitors. Generally, companies provide very limited access to the trade secrets, execute strong employee agreements, and monitor the protection across all steps of the business process. An excellent example of protecting trade secret is the Coca-Cola’s recipe, which is kept safe by a trade secret. Practically speaking, trade secrets may last for decades or even more, whereas a patent is only good for approx. 10-12 years in the pharmaceutical industry, as it starts with the product’s development, which can take 8-10 years out of the total 20 years of protection.
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