In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally.
In part 1 of this panel discussion with The Center for Biosimilars®, 3 experts assess the state of the biosimilars industry in India and some of the biggest issues facing its success.
Gaps in the Guidelines
Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois, Chicago, contends that India’s guidelines involve requirements for unnecessary nonclinical data, such as from animal trials, and do not contain acceptable requirements for the number of patients needed to conduct a clinical study.
Anurag Rathore, PhD, a professor in the Department of Chemical Engineering at the Indian Institute of Technology in Delhi, India, states that a lot of India’s biologics issues aren’t necessarily with the guidelines, but are with guideline adherence, in that most regulators have specialized in small molecule drugs and have limited experience working with biologics.
Economics of Affordability
Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, explains why reducing biosimilar development costs without sacrificing clinically relevant data is important, including that most patients with cancer are from low- and middle-income countries, where affordable drugs are needed.
Rathore notes that India has tremendous skill already with producing safe and effective drugs because roughly half of the products on the US market are manufactured in India despite challenges. He agrees that it’s critical for India to manufacture biologics economically to improve affordability, but that it’s also important to improve the reliability of data coming from clinical trials.
Cornes states that India does have the resources to produce world class biosimilars but that he has concerns over whether there are too many small players and too much competition in the Indian marketplace, such that the large companies with the quality and resources to compete globally may find it hard to get the recognition they deserve.
Niazi states that the standards put forth by the Central Drugs Standard Control Organization (CDSCO) are not optimal to allow for trial data to be accepted worldwide, which results in a lot of Indian companies doing only what is needed to receive approval in India. This means that none of the locally produced biosimilars sold exclusively in India could qualify for use in Western countries without companies having to redo their trials from scratch.
Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval
July 24th 2024Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.