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October 2017

Cancer Research in India

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Cancer research in India has grown extensively over the last two decades, both in terms of size and impact. Government and state policy makers, scientists and clinicians in India have vigorously supported cancer research from studies to achieve large-scale health outcomes using low-tech solutions to areas of highly advanced cancer science. However, there remain many issues which reveal serious gaps in public policy in India. Most importantly, there is a clear need for setting a strong research agenda across the country. 

Research systems in India need to take into consideration not only modern medicine, but also traditional medicine or what is now referred to as ‘AYUSH’: ayurveda, yoga, unani, sidha and homeopathy. With this inclusion, the research agenda for cancer becomes vast and diverse and the task of delivering cancer research programs becomes more nuanced compared with high-income, developed countries.

Adding to this complexity is the variation in research activity across different states and union territories in India. Worldwide, evidence has shown a correlation between research activity and positive outcomes for patients. However, there are large gaps in research output between states within India. Research programs have to, therefore, take into account the capacity of each state to support research infrastructure, training, and patient care. These gaps can be addressed with greater collaboration between the states and with international stakeholders. Greater engagement with pharmaceutical industries at a regional level, research on repurposing of medicines, and development of novel formulations will also go a long way in improving access to more affordable cancer treatment.

Eminent researchers and medical practitioners have recommended that policy for cancer research and development be embedded within the National Cancer Control Program. This will impact patient outcomes and improve cancer care in India and help achieve important objectives: it will help identify priority areas for research, build academic networks, assess cost effectiveness and impact of research on individual and population outcomes and develop human resources for research.

With the right support, India has the capability to be a world leader in cancer research that delivers cost-effective solutions to deliver affordable cancer care.

Biosimilars in Oncology-way to go?

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The term “biosimilar” refers to a biological product that is highly similar to a licensed biological agent (reference or originator product) with no clinically meaningful differences in terms of safety, purity, or potency. Biological agents or “biologics” are widely used in oncology practice for cancer treatment and for the supportive management of treatment-related side effects.

As biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic, exact versions of the innovator biologic. Biosimilars have the potential to increase access and provide lower-cost options for cancer care as patent protection for some of the most widely used biologics begins to expire. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization strategies that can facilitate their robust clinical development.  As such the Indian guidelines on similar biologics are comparable in many respects to biosimilar guidelines of USA and EU. India has adopted a “sequential approach” (like “stepwise approach” – US and EU) to market biosimilar products.

PROPERTIES GENERICS BIOSIMILARS
SIZE Small Large
MOLECULAR WEIGHT ~150 Daltons ~150,000 Daltons
STRUCTURE Simple and well-defined Complex with potential structural variations
MANUFACTURING Predictable chemical process to make identical copy Specialized biological process to make similar copy
COMPLEXITY Easy to fully characterize Difficult to characterize
STABILITY Relatively stable Sensitive to storage and handling conditions
ADVERSE IMMUNE REACTION Lower potential Higher potential
MANUFACTURING QUALITY TESTS ≤ 50 ≥ 250
APPROVAL REQUIREMENTS Small clinical trials in healthy volunteers Large clinical trials in patients

 

With Biosimilars, not only will patients have more treatment options, but they will also potentially have the ability to get the medications they need for serious disorders at much lower costs than the original biologics. With biosimilars becoming more widely available, consumers can expect the same efficacy, safety and reliability as the original medication at a reduced price.