Consumer New Delhi: Renowned consumer activists have caught Biosimilar Makers candid. The makers of this genre of medicines are batting for relaxation of conditions for marketing approval. The activists have said without mincing words that patient safety cannot be traded for access and affordability. On Biosimilars’ attempt to skirt prerequisites, the activists have put their feet down, saying the safety question should be off limits for any kind of compromise.

Hot on the heels of a letter written early on this month to secretaries of Union Health Ministry and Department of Biotechnology for cutting corners, consumer activists have red flagged the attempt citing recent mishaps due to ‘made in India’ medicines which have badly battered the image of pharmacy of the world that India prides itself upon. The makers seem to be in a hurry to capture the market coxing drug regulators to throw caution to the winds.

The letter in the name of representatives of various civil society, community organizations, health organizations and patient groups asks for waiving of conditions imposed by current Indian Biosimilar Guidelines namely mandatory animal studies and comparative safety and efficacy studies for marketing approval.  Branding these conditions major barrier in the way of biosimilars trying to enter the market, the letter flaunts the question of access and affordability. The argument of sidelining safety concern for making medicines affordable does not sit well with consumer interest advocates.

Prof. Bejon Misra, internationally renowned consumer policy expert, activist and Founder Director, Patient Safety and Access Initiative of India Foundation is categorical saying safety question cannot be given a go by when it comes to medicine, nowise.  In his official statement, prof Misra said, “Patient safety should be of paramount importance while approving pharmaceutical products in any market. Clinical trials and safety efficacy studies are vital requisites to ensure products launched in the market are safe and efficacious. The safety of patients cannot be compromised for the sake of affordability. There is no denying that biosimilars can significantly bring 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.

In fact, because biologics are different than conventional chemical molecules and are complex and difficult to develop, it is important that biosimilar undergo rigorous testing and clinical scrutiny to ensure they are safe and efficacious.  Comparative safety and effectiveness data is necessary to support the demonstration of biosmilarity. The Indian biopharma industry is already struggling to keep up with international quality and testing standards, given the existing regulatory inadequacy.

Further relaxations in the current regulations will not only be bad for India’s reputation on the global map but also put Indian patients at a huge risk. When it comes to patient lives, we cannot take a chance.  Any slips, in the name of cost-cutting, could prove to be fatal, for patients and for the industry, more than ever isthe US and Europe for biosimilar testing shows the lack of a step-wise approach taken globally to demonstrate biosimilarity. Most Indian companies are not able to globally launch products made for the Indian market. Are the lives of Indians not worthy enough to access bio-drugs that meet international benchmarks?

Anurag S. Rathore, Ph.D., Coordinator, DBT COE for Biopharmaceutical Technology, Professor, Department of Chemical Engineering (Jointly with) Yardi School of Artificial Intelligence, Indian Institute of Technology, Delhi is equally concerned by the attempt and has unambiguously put his view points as follows.

“Indeed clinical trials continue to be the single largest contributor to the development and commercialization of a biotherapeutic product. This is even true for a biosimilar, class of compounds for which the quantum of required clinical trials is already substantially reduced. It is also true that biosimilars cost significantly more than their pharmaceutical generic counterparts, thereby impacting their affordability and accessibility.

These facts have been fuelling calls for the reduction or even elimination of clinical trials as this would substantially lower the cost of manufacturing and make them more affordable. While these calls are gaining momentum, the regulators need to keep the delicate balance between affordability and patient safety. If clinical trials are significantly curtained or worse totally eliminated, the probability of getting a therapeutic product with compromised safety and/or efficacy increases. Such incidents will not only lead to the loss of precious patient life but also irreversibly dent the global view of Brand India. Loss in credibility will significantly nullify our efforts to bring Indian biotherapeutic products to global markets.

Perhaps the wisest line of action is to be in the middle, carefully balancing the above mentioned counter factors. For products that have been on the market for more than a decade, mechanism of action is well understood, multiple biosimilars are on the market, perhaps exhaustive analytical characterisation with very limited clinical studies can be the basis of approval. Products like GCSF, epoietin alfa, insulin fall in this category.

However, for most other biosimilar products, in particular monoclonal antibodies, adequate clinical trials for demonstrating safety and therapeutic equivalence are essential for ensuring global acceptance of quality of approved biotherapeutic products. It should be noted that the size of clinical trials that is required for approval in India is amongst the smallest globally,and significantly smaller than what would be required for approval by FDA or EMA.”