Biosimilars, Generics, and the Sustainability Nexus

Several precarious issues were on everyone’s mind at this year’s GRx+Biosims meeting, organized by the Association for Accessible Medicines. This conference combines the interests of generic manufacturers and biosimilar makers, and one particular speaker, emphasized where these interests meet today: the sustainability of both industries.

Christine Baeder

Christine Baeder, Senior Vice President, US Generics, Teva, pointed out that “the economics of the generic drug is broken, resulting in the critical drug shortages we are seeing today.” She is worried that a similar, basic financial factor will bleed into the biosimilar industry as well; the inability to not be able to make a profit on a competitive biosimilar will drive manufacturers out of the market. (I will have more on this issue at a later date.)

Unlike for most branded and specialty pharmaceuticals, generic drugs cost more to purchase in Europe than in the US, said Ms. Baeder. The implication is that EU countries have figured out that they need to pay generic manufacturers a level of reimbursement that may assist their sustainability.

Even though generics and biosimilars are saving the US health system billions of dollars, the cost patients pay at the pharmacy does not generally reflect this. “If I provided a generic drug to the pharmacy for just $2.32 per month, why then would a patient then complain to me that she was just charged far more at the pharmacy for the drug than the actual cost of the medicine.” Therefore, “the savings to the system that are gained by generics and biosimilars are not necessarily seen by the patient.”

“I am deeply concerned about the effect of the [Inflation Reduction Act] and its potential effect on the burgeoning biosimilar market,” said Ms. Baeder. “I believe it will erode incentives for biosimilar and generic development,” threatening to destroy the biosimilar industry.

The Need for a Global Reference Comparator

The incentive to develop biosimilars is limited by the cost of bringing these products to the market. Streamlining biosimilar development is a popular topic, and the use of a globally accepted reference product would be a great help to reducing cost, according to Elena Wolff-Holz, MD, PhD, Vice President, Global Head of Clinical Development for Biocon Biologics.

Elena Wolff-Holz

The FDA still requires bridging studies when a clinical trial utilizes an EU-sourced reference product rather than its US-made counterpart. The need for the bridging study is itself questionable, said Dr. Wolff-Holz, as “no bridging study has failed to prove the comparability of the US and EU reference products.” She reminded the audience that all prospective ustekinumab developers not based in America will have to perform a three-sided pharmacokinetic bridging study.

If needed, the bridging study also requires the additional purchase of expensive samples from the reference manufacturer. “Purchasing sample and doing the bridging studies could be 10% to 25% of the total biosimilar development cost,” Dr. Wolff-Holz stated.

The designation of global reference comparator would have multiple benefits for prospective biosimilar makers. It would: (1) eliminate the need and associated cost of bridging studies, (2) enable US biosimilar manufacturers to purchase sample reference products in Europe where the cost is lower, and (3) streamline the time needed to commercialize biosimilar products.

In Other Biosimilar News

Boehringer Ingelheim announced that it was offering a dual pricing option for Cyltezo®, their interchangeable, low-concentration formulation of adalimumab. Boehringer is offering a WAC discount of 81%, as an alternative to its 5% discount to Humira’s current list price of $6,922 per month. They join Amgen, Biocon Biologics, Sandoz, and Celltrion as offering dual price options (in branded or unbranded form).

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