Biopharmaceuticals are medicines made from living cells (such as yeast and bacteria). The conventional drugs, by contrast, are made from chemicals. Biopharmaceuticals are used in the treatment of chronic diseases such as cancer, diabetes, cardiovascular disease and auto-immune diseases. Biopharmaceuticals are put in two categories — biologics and biosimilars. Biosimilars resemble the prescribed biologics cleared by authorities. In fact, they are follow-on biologics. They are equally efficacious and safe as the first biologic version.
India biopharma industry is fastest growing globally. India is a pioneer in global biosimilars, say the first country to approve a biosimilar for Hepatitis B.
In India, there are 98 approved biosimilars, of which at least 50 are available in the market.
Many biologic products will lose patent between now and 2030. Thus, there is opportunity for Indian biopharma to launch biosimilars.
The government promotes acceleration of the production of biopharmaceuticals. Despite this, India has only a 3 per cent share of the global biosimilar market.
Patenting Process
To encourage innovation and to allow the recovery of drug development costs, a 20-year patent is given for exclusive marketing of patented products. As soon as the patent expires, there are low-cost versions of the patented drug. Biosimilars are such low-cost drugs.
However, exclusivity of patented products is lengthened by making minor modifications in the patented drug and getting a renewed patent. It thus blocks the entry of low-cost economic versions of patented drugs and biosimilars. To illustrate, trantuzumab (Herceptin), a biologic used to treat breast cancer, got a new patent by introducing a SC version. This is patent evergreening.
India guards against patent evergreening by Section 3 (d) of the patents Act,1970. It rejects renewal of patents by small innovations that lack substantive improvement. Glivec (Imatinib) used to treat leukemia from Novartis was denied patent under this clause. The Courts later upheld the decision. Section 3(i) of the Act restricts patenting mixtures of known compounds unless a synergistic effect is proven, Section 3(e) of the Act prevents patents on treatment methods.
Despite these safeguards, there ae hurdles in launching biosimilars. Pertuzumab, for certain breast cancers has become controversial. Even in India, more than 70 per cent of granted patents are of products with minor or secondary modification. In the US, 74 per cent patents are of the existing drugs. Many drugs receive patents to lengthen their life. The European Union has framed guidelines and has seen significant biosimilar adoption. India should be more proactive in this respect.
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