Mylan Head Warns of "Whisper Campaign" Against Biosimilars

At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.

Reimbursement Challenges

Among the key challenges for biosimilar uptake in the United States has been reimbursement. Recently announced changes to CMS’ reimbursement policy for biosimilars, which will assign unique J-codes to individual biosimilar products rather than grouping them under shared codes, put industry “in control of our own destiny,” said Kokino, who sees greater competition as healthy for the marketplace.

However, he hopes that declines in price will not create a “race to the bottom” effect as developers seek to undercut one another’s prices. Small companies that have made large investments in a biosimilar may feel that they have to sell their products as quickly as possible in order to recoup their investments. While cutting prices and selling at high volumes may be good for the individual company, it can lead to price drops that are unsustainable for the industry.

Reimbursement for biosimilars in the European setting has not been simple, either; Kokino recalled a time in his career when he was involved in negotiating reimbursement with England’s National Health Service for an erythropoietin biosimilar. “At that time, what they wanted was £1 for 1000 units of EPO…you can’t buy a sandwich and drink for [that amount],” he said. “Listen, [developing biosimilars] is not an easy thing to do…[it is part of the reason] we have to charge what we do.”

“Whisper Campaign” Against Biosimilars

Kokino also highlighted reference product sponsors’ efforts to cast doubt on biosimilar therapies. He noted that in a prior role in his career (at a company that he did not name in his talk), he served as the lead on an anti-biosimilars effort. “We had full-out campaigns to prevent biosimilars,” he said, explaining that representatives would speak to regulators and plant “that little seed of doubt that caused consternation” about biosimilar safety.

While European regulators became “fed up” with what Kokino termed a “whisper campaign,” tactics have changed to suit the current state of the US marketplace; according to Kokino, there are “certain representative telling physicians, ‘don’t use the biosimilar until it has an interchangeability designation, because it’s better.’ It only takes that 1 seed of doubt” to influence prescribing behavior despite clinical evidence that shows biosimilars to be safe and effective.

Balancing Cost Savings and Patient Access

Finally, Kokino referenced a recent RAND corporation report that estimated that using biosimilars could save the United States $54 billion over 10 years. “It’s like lottery numbers. It’s like Powerball,” he said, but added that it is not yet clear how the US will reach those savings in the face of its unique market challenges.

He also noted that a focus on savings to health systems risks overlooking the critical importance of improving patient access. Kokino discussed his own sister’s treatment for breast cancer, recounting his frustration at learning that she would be denied access to some key therapies on the basis of cost. “Unless you have a patient advocate to gain access to some of these medicines,” he said, important treatment opportunities “are lost.”

“Everyone talks about [a drug’s] value to the health system…if you shift your focus away from the value to the health systems and shift your attention to how we can gain access for patients, I’d venture to say we could find a solution to this and maintain a fair balance” in the marketplace, Kokino added.