Dr Kashyap Patel: Misleading Reference Product Advertising and the Damage to Biosimlars' Reputation

Regulatory agencies have already begun calling companies out for misdirecting the public about the safety and efficacy of reference products in comparison to biosimilars, and it's important to continue to do so, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Regulatory agencies have already begun calling companies out for misdirecting the public about the safety and efficacy of reference products in comparison to biosimilars, and it's important to continue to do so, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Transcript

How important do you think truthfulness in advertising is to ensuring a fair and competitive marketplace for biologics, and do you think originator companies are playing fair?

So, I'm not actually privy to kind of dissect out the legal part of that, but I do feel that transparency is a foundation of providing better health care. And I did realize I think a couple of companies were actually, I would say 5, told off by the either FDA or some other authority, I don't recall which authority actually. But someone from the regulatory agency did kind of call them out for these sort of information, which would dissuade patients or beneficiaries from going for the biosimilars. They've been used for close to 15 years across the world. If you look into Europe, I think at last count, there were about some 100 million unique doses of the biosimilars used between different parts of the world. And I don't think there has been any significant safety issue that has come to light that will be a red flashing light. So, I do have kind of my reservations against the practices that misdirect populations of patients and I do feel that the industry should be staying within their ethical and moral guidelines, rather than trying to look into how can they increase the sales. I think the Onpro has its own rules. I mean, don't get me wrong. I asked my patients if they're comfortable, if they have enough money to pay out-of-pocket costs, if they're willing. We give them option we discuss the product with them and I think our patient population in rural South Carolina has been more comfortable with traditional use of less expensive alternatives rather than going for a more expensive alternative.