India’s race to open the market to Biosimilars: Understanding the requisite checks and balances to ensure patient safety


With the recent speculation on the ease of entry of biosimilars in the Indian market after a letter by a group of patients’ rights organizations came to the fore, a conversation with Dr. C.S.Madhu, Senior Consultant and HOD Oncology at Lourdes Hospital, Cochin sheds light on what biologics and biosimilars are, drug efficacy and safety, challenges faced in treatment of complex diseases like cancer, where they stand in terms of patient safety and the checks and balances needed to ensure drug safety and efficacy.

Q1. Both biologics and biosimilars are used to treat complex diseases like cancer. Can you help understand what they essentially are and what is the difference between the two?

Biologics are a class of drugs that are produced using a living system, such as a microorganism, plant cell, or animal cell. They are different from chemical molecule drugs and are more complex and larger. With scientific advancement, particularly in biotechnology, researchers identified specific targets for intervention. Biologics have the potential to be tailored and are designed to offer more precise and targeted treatment. The development of innovative drug delivery systems has also contributed to the success of biologics. Biologics have demonstrated significant therapeutic benefits in various diseases, including cancer, autoimmune disorders, and infectious diseases. The growing global demand for effective and targeted therapies has encouraged pharmaceutical companies to invest in biologic drug development.

Biosimilars on the other hand, as the name suggests, are a biologic ‘similar’ to the original biologic approved by regulatory authorities (e.g., US FDA or EMA). They are not exact copies of the biologic. Consequently, since a biosimilar is not a generic (exact copy), more studies are typically needed for regulatory approval of biosimilars to ensure that any differences with the innovator drug do not affect patient safety or drug efficacy.

Biosimilars are priced at a minimum of 50 percent lower than the original biologic medicines. The reason behind this is the fact that biologics are backed by robust clinical data and randomized clinical trials whereas biosimilars do not undergo sufficient testing. While clinical trials and animal studies make biologics more expensive, they also ensure efficacy and safety of the drug, whereas every batch of a biosimilar may be different therefore making intra-batch and inter-batch quality assurance extremely crucial.

Q2. What has been your experience with prescription of biologics and biosimilars? Any examples of use cases that you can share to demonstrate this?

As a doctor, we place safety of the drug and patient well-being as priority. Nonetheless, I do get patients who cannot afford biologic drugs either due to the cost or sometimes due to the availability, so we do prescribe biosimilars in such cases.

An effective cancer drug is meant to induce remission, consolidate remission, and prevent relapse. In cancer treatment, substandard medicine results in recurrence and creates drug resistance. A relative with lymphatic leukemia suffered from relapse being on the generic biologic.

If biosimilars are backed with rigorous clinical trials and ample evidence data in the public domain, doctors would be more confident in prescribing them. While affordability is definitely a factor, we cannot turn a blind eye towards drug safety and efficacy as well as patient safety which lie at the heart of any treatment for a doctor. These are non-negotiable pre-requisites of any treatment.

Q3. From a recipient perspective, do patients ask specifically for biologic drugs or biosimilars? Is there enough knowledge amongst patients on this?

Patients take drugs largely based on what is prescribed to them, entrusting doctors with their lives and decision-making often hinges on the cost factor in India. In the US, insurance companies pay for medical companies while in the UK, the government bears the cost. India does have such a support system for patients. We have to pay for our own medical costs and subsequently, poor people end up purchasing the cheaper version (biosimilars). For example, there is a biodrug which controls the WBC count (white blood cell) available for INR 30-40 in the market – this is close to impossible if the drug has undergone the much needed tests and trials.

There isn’t much awareness amongst patients on the side-effects of biosimilars, which is also difficult to trace in a short span. Therefore, it is a must that we only allow those biosimilar products in the market which have undergone the necessary rounds of clinical trials and testing and are quality assured and safe. Another solution could be that medicines are made accessible either by subsidies or insurance covers but compromising on testing processes to bring down cost cannot be an option. We must prioritize patient safety by focusing on drug safety.

Q4. In the context of patient safety and efficacy of treatment, where do biologics and biosimilars stand?

Biologics hold great potential to drive treatment for critical diseases like cancer. For instance, biologics can be used to treat cancer in a variety of ways. Apart from immunotherapy which helps the body’s own immune system to fight cancer, biologics are also designed to slow down tumor growth and progression, or even help the body recover from other anti-cancer treatments. This also makes it important to ensure quality, safety and efficacy of biologics or biopharmaceutical products through rigorous clinical trials and post marketing pharmacovigilance studies.

Biosimilars are a class of drugs designed to increase access for patients who need treatment with a biologic medicine. Biosimilars are products that demonstrate similarity in quality, safety and efficacy with the original or reference biologic product. We must understand that similar is not the same. Therefore, biosimilars are not considered interchangeable therapeutic alternatives over original biologics – there are concerns regarding their similarity in effectiveness and safety with the reference product. The degree of drug effectiveness also impacts the survival rate of patients.

Biosimilars can certainly be instrumental in significantly bringing down the price of essential biologics that are used for critical diseases including cancer but that does not mean biosimilars are allowed without adequate safety studies. A recent letter to the Health Ministry has requested for a waiver in animal and clinical studies calling them barriers. They are anything but barriers. Such studies help assure the quality and efficacy of biosimilars, keeping patient safety in mind.

In fact, because biologics are different from conventional chemical molecules and are complex and difficult to develop, it is important that biosimilars undergo thorough testing and clinical scrutiny to ensure they are safe and efficacious. Comparative safety and effectiveness data is necessary to support the demonstration of biosimilarity. Patient safety must be of paramount importance and cannot be compromised at any cost.


Q5. As a healthcare professional, what kind of processes do you think can be put in place to ensure safety and effectiveness of these class of drugs?

As mentioned before, clinical trials and safety studies are critical checks and balances for quality control of biopharmaceuticals. Such processes help ascertain drug safety, which is primary, and then efficacy. Animal studies are a must to determine toxicity before use of the drug on humans. Because biosimilars are produced in batches, intra-batch testing and quality control should be a requisite to establish quality assurance.

Once a biopharmaceutical drug is in the market, there needs to be a strong pharmacovigilance system as well so potential risks and immunogenicity can be identified and tracked. This data needs to be accessible and in the public domain to prove evidence of safety and efficacy.

At the same time, too many approvals and too many manufacturers of biosimilar drugs is also problematic. Approvals should be given judiciously, based on quality standards and processes of the manufacturing company. Hoards of manufacturers of these medicines just makes it a game of sales and targets, taking away from the core aim of saving and protecting patient lives.

Overall, our regulatory framework that guides the manufacturing and sale of biopharmaceuticals needs re-visiting to closely understand the functionality of clinical trials and safety studies leading to manufacturing of drugs that are safe and effective. We cannot take the risk of repeating the same story that our generic drugs are facing globally. We have a reputable pharmaceutical industry, and this track record can be replicated for biopharmaceuticals as well with the right checks and balances.

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