Cancer, one of the most dreaded diseases, has become a worldwide epidemic. In India too, the number of people suffering from cancer is rising steadily. On the plus side, there has been significant progress in treatment in recent years, with several highly effective medicines being developed for various types of cancer. Due to decades of research, many of these medicines, once very expensive due to royalties, have now become more affordable. Still, some new treatments, which may offer even better outcomes, remain out of reach for many Indian cancer patients.
A key example of these treatments is biologics—complex, large-molecule drugs derived from living cells. Biologics precisely target cancer cells and have shown great promise, such as trastuzumab for breast cancer and bevacizumab for colon and other cancers. But many of these drugs are prohibitively priced in India.
This is where biosimilars come in—lower-cost, highly similar versions of these biologic drugs that offer a more affordable option for cancer patients. These medicines have brought a ray of hope in the fight against cancer. For instance, in January, Aurobindo Pharma received approval to market the biosimilar version of trastuzumab in India, while in June, Biocon Biologics was granted approval by the European Medicines Agency (EMA) to produce biosimilar bevacizumab at its Bengaluru facility.
But even though India is making huge strides in the biosimilar sector, there are still several barriers to availability, which must be addressed urgently.
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Why biosimilars are a game-changer
The decoding of the human genome had a major impact on health research, helping us to better understand diseases and develop personalised medicine tailored to different patients. An outcome of this research is biologics, which are made from living cells, usually complex proteins, using genetic engineering. Biologics have made targeted therapy possible in conditions like cancer and autoimmune diseases.
Examples of biologics include drugs like pegfilgrastim, which stimulates white blood cell production in chemotherapy patients, and adalimumab, used for autoimmune conditions like rheumatoid arthritis. In cancer treatment, biologics such as trastuzumab and pertuzumab target HER2-positive breast cancer. These new drugs have given new hope to millions of patients.
However, many cancer patients, especially in developing countries, cannot take advantage of these new treatments because they are either unavailable or too expensive. And that’s where biosimilars come to the rescue—similar versions of already-approved biologics, which are safe, effective, and available at a lower cost.
Just as generic medicines reduce costs for chemical drugs, biosimilars make biologic treatments more affordable. However, unlike chemical generics, biosimilars are more complex to produce and have to undergo very stringent evaluation and testing to ensure they meet the same standards for safety and efficacy as the original biologics. They also have to go through rigorous regulatory processes for approval.
In India, it’s estimated that about 1 in 9 people are at risk of developing cancer in their lifetime. And nearly 60 per cent of breast cancer cases are diagnosed at stage 3 or 4, when the cancer has spread to other parts of the body. This puts a heavy financial burden on both individuals and the public healthcare system.
In this scenario, it is fortunate that India has among the world’s highest number of biosimilars approved in the domestic market. Yet, for the masses, accessing these life-saving drugs is still not as straightforward as it should be.
Where is the hurdle?
Patent challenges, complex regulatory processes, and market entry barriers often stand between patients and biosimilar drugs. The question: Will we be left behind in effective cancer treatment due to these barriers?
The situation demands immediate action. In India, we have to create an environment where breakthroughs like biosimilars can reach cancer patients at affordable prices.
One major obstacle is evergreening, a strategy used by patent holders to maintain their control. By filing multiple patents for even very minor modifications, these companies extend their market exclusivity and delay the entry of more affordable biosimilars. As a result, patients suffer.
Notably, Section 3(d) of the Patents Act was designed to stop such practices by preventing patents for minor modifications. This was reinforced by the Supreme Court in the 2013 Novartis vs Government of India case over the cancer drug imatinib mesylate.
Nevertheless, original biologic manufacturers still find ways to delay biosimilar access. They aggressively challenge biosimilar producers in court and lobby against reforming biosimilar marketing approval regulations to prevent biosimilar manufacturers from obtaining marketing approval quickly, even though India’s IPR regime doesn’t provide data exclusivity. As a result, biosimilar manufacturers are forced to conduct their own expensive trials, delaying the affordable production of biosimilars.
This issue is not limited to India. In the US too, companies are adopting similar tactics to create obstacles for the entry of biosimilars in the market.
To deal with this problem, the Increasing Access to Biosimilars Act was introduced in the US Congress in March 2023. The legislation aims to increase competition in biosimilars and reduce the financial burden on patients. It’s believed that biosimilars can save the US healthcare system up to $133 billion if they are made accessible.
The Singapore government has integrated biosimilars into its public health system, leading to significant reductions in medicine costs. A recent study of biosimilars of five drugs found that within a year of subsidy listing, the adoption rate of most exceeded 95 per cent. Overall, spending for the five biologic drugs dropped sharply after biosimilar subsidy listing, saving about $136 million over five years.
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What should India do?
Many measures are needed to increase the availability of biosimilars in India. First, misuse of IPR laws needs to be curbed, so that a balance is established between innovation and competition.
Second, there are many misconceptions about biosimilars among doctors and patients, which need to be addressed. For this, a comprehensive public awareness campaign is needed to build confidence in these life-saving medicines.
The clock is ticking fast, and without widespread access to biosimilars, thousands of cancer patients are losing their battle. Life-saving treatment is not a privilege but a right. The government and the healthcare system should understand this.
India’s biopharma industry has no dearth of knowledge, talent, and resources. We should not let the corporate greed of biologic patent-holders stand in the way of affordable and effective treatments for cancer patients.
Ashwani Mahajan is a professor at PGDAV College, University of Delhi. He tweets @ashwani_mahajan. Views are personal.
(Edited by Asavari Singh)