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In the day and age of IVF (in vitro fertilisation) grabbing the limelight across the world of science, medicine and business, another healthcare-pharma development is keeping the ecosystem engaged. It’s the biologics versus the biosimilar debate, which has taken a new turn in India with a recent letter to the health ministry, not just from pharma companies but also from representatives of civil societies, patient groups, community, as well as health organisations.
To put it simply, at the core of the debate is a basic premise that drugs must be affordable so that a large number of people can benefit. There’s no argument against the need for affordability, but the letter has asked the government to relax the guidelines related to testing and manufacturing of biosimilars in India to ensure that the treatment is affordable. The group has sought a revision of the Biosimilar Guidelines, 2016, saying that a committee, free from the influence of those promoting highly priced originator products, must work on a new set of norms.
On the other side, represented by research-oriented multinational pharma giants, some independent voices, and mostly anonymous doctors, have hit out saying there’s no sense in making drugs (biosimilars) without the regulatory rigour. The central question being posed by the opposing side is: What use is an affordable medicine if it cannot cure, or if it gives a side effect?
This is playing out somewhat like a patented medicine vs generic debate 2.0. But not exactly. Biosimilars are often referred to as copycat versions of biologics. In reality, things work quite differently in the biologics universe because of the complexities involved. The US Food & Drug Administration (USFDA) describes biological products as a category that includes vaccine, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. While biologics can be composed of sugars, proteins or nucleic acids, or complex combinations of these substances, they can also be living entities such as cells and tissues. Most conventional drugs are chemically synthesised and their structure is known, unlike biologics that are complex mixtures and are not easily identified or characterised.
Importantly, the USFDA states that biological products tend to be heat sensitive and susceptible to microbial contamination. “Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.’’ Biological products, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available. Cancer, kidney diseases, diabetes are among those treated with biosimilars at present.
The health regulator in the US points out that biosimilar is a biologic that is highly similar to and has no clinically meaningful difference in terms of safety, purity and potency from an FDA-approved biologic, or a reference product. The FDA approves biosimilars through what it calls “an abbreviated pathway’’. That means biosimilar manufacturers do not need to conduct as many expensive and lengthy clinical trials, resulting in drugs that are less expensive.
However, an abbreviated pathway doesn’t imply a shortcut in terms of safety, trials and efficacy. Biosimilars are evaluated for approval based on all the evidence presented by the manufacturer. Also, the FDA is emphatic that it evaluates each proposed biosimilar individually and advises manufacturers on the scope and extent of testing needed to show biosimilarity. Because it is made from natural and living sources, a biologic medication cannot be exactly copied and the information needed to demonstrate that a biologic is biosimilar to another biologic can be much more extensive than required for a generic. That’s how biosimilars are different from generic drugs and that’s why the mechanism of clinical testing of biosimilars needs to remain world-class.
In sync with the international norms, the Central Drugs Standard Control Organisation (CDSCO) and Department of Biotechnology issued guidelines on biosimilars in 2016, highlighting safety and efficacy. “A similar biologic product is that which is similar in terms of quality, safety and efficacy to an approved reference biological product based on comparability,’’ CDSCO had said while listing out detailed testing and manufacturing norms.
Even as the letter written by representatives of civil societies, patient groups and health organisations cited relaxed rules on biosimilars by certain global bodies, US-based public health activist and pharma insider Dinesh Thakur has attempted to clear the air. Mr Thakur, who came into prominence as a whistleblower exposing violation of good manufacturing practices by Ranbaxy years ago, has been focused on improving the quality of affordable medicines across the world, including the US. As someone who’s seen the world of copycats from close quarters, Mr Thakur has pointed out in a recent published piece that unlike small-molecule generics, biosimilars are subject to much stricter regulatory requirements worldwide.
“For instance, to gain approval in most jurisdictions, a generic version of a small-molecule drug like paracetamol needs to demonstrate that its dissolution rate is the same as the innovator drug, which has already undergone clinical trials.’’ Responding to the letter that certain global regulators have eased the biosimilar rules, Mr Thakur has been quoted as saying that the UK’s Medicines and Healthcare products Regulatory Agency did not offer a blanket waiver on animal studies for the approval of biosimilars in 2021, rather it opted for a case-to-case approach. The World Health Organization guidelines too do not advocate blanket waiver.
Back in 2017, medical journal Lancet had said that the biosimilars market is rapidly expanding and that they have the potential to offer affordable treatment options. Industry estimates suggest that the biosimilars market in India would grow more than 25 per cent annually to cross the $2 billion mark by 2030, from $350 million today. But the market will look up only if we don’t drop the guard in regulating the pharma industry.
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