In the midst of the pandemic, where all discussions are focused on the availability of vaccines, certain other aspects which have lost the spotlight requires some attention.

The waiver on the TRIPS agreement if implemented might provide a solution to the availability of vaccines to some extent.

There are a variety of diseases that affect the human population, diseases like cancer are increasingly becoming common among us, while there are certain other diseases that only affect a small percent of the population.

I remember my teacher saying once, that colonization comes in different forms at different times. Trade is one area where we are still enslaved to the international mandates formulated by the countries of the Global North at the cost of our own constitutional principles.

In order to protect the interest of our nation, at least with regard to health, we need to rise above the clutches of the 'Global Pharma' and the institutions sailing along with them.

Biological Products or biologics are the new game changers in the pharmaceutical industry.

Unlike the small molecule drugs (drugs manufactured through simple chemical processes), it is very difficult to manufacture the generic version of Biologics.

This in turn has contributed to the soaring prices of biologics.

Unlike small molecules, access to affordable biosimilar drugs is becoming a dream unrealizable for the common man in India.

Some important questions which need to be asked in this context are,

• Why aren’t affordable biosimilars available in India?

• Has this always been the case?

• What needs to be done?

Let us try to understand the situation by looking at a case study which will give you the tip of the iceberg.

Last year online portals had covered the news regarding a patent granted for the anti-cancer drug Nivolumab, Opdyta (trade name) manufactured by the pharmaceutical company Bristol Myers Squibb.

The patent application filed in 2007 had to overcome four pre-grant oppositions in order obtain registration in 2020.

The drug had been granted approval by the US FDA in 2014 and was later approved and launched in India a few years before the patent grant.

Nivolumab acts as a wonder drug for people suffering from metastatic lung cancer (cancer that is spread to the lungs from other parts of the body).

Such drugs are used in a line of treatment for cancer known as immunotherapy whereby the immune system of the cancer patient is strengthened in order to fight the particular cancer.

I came across a patient X (name kept confidential) who has been using the drug for the past 3 years.

The dosage of the drug advised by the doctor to him was 240 mg every two weeks, the cost of which would roughly amount to Rs.225000!

However, the company had been offering the medicine under a patient assistance scheme, whereby a vial of 100 mg would be given free on each purchase of a vial of 100mg.

In effect, he would have to pay an amount close to Rs.1,25,000 in order to get his dose administered every two weeks, which is still a huge price to pay.

In a span of one year or more, the scan reports of his lungs showed that there was no sign of lesions in his lungs, he was completely cured of the disease.

Even though the dosage had been decreased to a monthly basis and certain reductions were offered from the pharmaceutical company, the total money spent roughly calculated till date (3 years) for the drug amounts to a whooping Rs 34 lakhs!

However, the substantial population in India will never be able to reap the benefits of such a drug.

Before the patent had been granted in mid of 2020 the pharmaceutical company had already earned considerable profits from the Indian market.

Now with the grant of a patent, we need to wait and see the market strategy that will be adopted in the coming years. It is pertinent to note that this drug has been included in the 21st list of WHO's Model List of Essential Medicines in 2019.

The National Pharmaceutical Pricing Authority (NPPA) while regulating the price of 42 anticancer drugs in 2019, had left out this drug, the probable reason being that it was under patent examination, since a medicine once granted a patent is exempted from price control for a period of 5 years in India.

So when do we formulate a policy for regulating the price of patented medicines?

Now that the drug is patented, it is free from the clutches of compulsory licensing too for a period of 3 years.

Coming back to the questions raised earlier on the availability of affordable biosimilars in India, it is understood that the change in the guidelines governing marketing approval of biosimilar drugs in 2012 resulted in the current situation.

Prior to 2012, there was no mandate for conducting comparative phase 3 clinical trials for biosimilars in order to prove their comparability to reference/originator drugs.

The similar biologics were approved by the Review Committee on Genetic Manipulation (RCGM) of the Department of Biotechnology (DBT) and Central Drugs Standard Control Organization (CDSCO) using an abbreviated version of the pathway applicable to new drugs on a case by case basis.

However, these regulatory agencies formulated a set of guidelines in 2012, the “Guidelines on Similar Biologics, Regulatory Requirements for Marketing Authorization in India, 2012” which brought such an additional requirement.

Even though the guidelines were amended in 2016, this situation still persists. The revised guideline of 2016 did not prove to be better in order to deal with the delays caused in the approval of biosimilars.

The present guidelines reflect the requirements posed in WHO’s Guidelines on Evaluation of Similar Biotherapeutic Products (SBP Guidelines), 2009 which require, “head-to-head comparison of a biotherapeutic product with a licensed originator product with the goal of establishing similarity in quality, safety, and efficacy. Products should be compared in the same study using the same procedures”.

While conducting comparability exercises, in order to prove the safety and efficacy of biosimilars comparing it with the originator/innovator drug, results are likely to show differences between the both.

Hence, requiring Phase 3 clinical trials in order to demonstrate a similarity in the structural, chemical and biological characteristics of the biosimilar with the existing originator does not serve the intended purpose.

Easing the requirement to do comparability exercise will make it easier to develop more biosimilars, such as monoclonal antibodies and vaccines. On the other hand, mandating clinical trials makes the development of biosimilars costly and time consuming.

It is important to note that around 38 non-originator biosimilars have been approved for the Indian market prior to 2012 and no safety and efficacy concerns were raised on these products. Therefore, there is no clear scientific reasons to shift to WHO SBP Guideline.

A resolution had been adopted by the World Health Assembly (WHA) in 2014, raising concerns on the non-availability of biological products at affordable prices.

In addition, a memo had been sent to the WHO by 8 scientists across the world questioning the scientific basis of WHO SBP Guideline in 2019.

The basic purpose of introducing biosimilars is to reduce cost of biotherapeutic products and to make them more affordable and accessible. However, the present regulatory framework is not creating a conducive environment for the same.

Hence it is the need of the hour that the government steps in and takes urgent steps to revise the Guideline on Similar Biologics,2016 and waive the comparative clinical trial requirements in the light of new scientific and technological developments.

This year while the World Intellectual Property Organization had observed the World IP Day adopting the theme “IP and SME’s”, it must also take note of the fact that it is yet to designate health as a main theme since the current situation demands of it.

(Naveen Gopal is a Research Officer under the DPIIT Chair on IPR in the Inter-University Centre for IPR Studies, Cochin University of Science and Technology and a Ph.D. candidate at the same Centre, pursuing research in the area of Trade Secrets.)