AMCP Nexus 2021: Biosimilars Are Gathering Momentum — and Interchangeability May Not Matter for Many of Them

Jeffrey Casberg, M.S., RPh, was a speaker at one of the three sessions devoted to biosimilars at the AMCP Nexus 2021 meeting in Denver, and he is not alone in believing that biosimilars are gathering momentum.

“I think the theme is that it seems like the tide is turning, market share is picking up, adoption is picking up,” said Casberg, who is vice president, clinical pharmacy, for IPD Analytics, a drug management and market access company, in an interview with Managed Healthcare Executive®.

Jeffrey Casberg

Casberg said he expects less push back from physicians as they prescribe biosimilars and their patients don’t report adverse reactions. And like many in the pharma industry he has an eye on 2023 when biosimilars to Humira (adalimumab) are expected to come on the market.

“I think over next 24 months, including the launch of the Humira biosimilars, will be the turning point,” he said.

Much has been made of interchangeability of biosimilars — whether the biosimilar can be substituted for the brand-name reference product at the pharmacy without the prescriber getting involved. Casberg said interchangeability will be a major factor in the insulin market because insulin tends to be dispensed at regular pharmacies. The FDA approved the first interchangeable insulin product, Semglee (insulin glargine-yfgn) in July. The reference brand-name product is Lantus (insulin glargine). But Casberg said interchangeability may not matter as much for the biosimilars dispensed through specialty pharmacies.

“Specialty pharmacies tend to have a lot of patient-provider contact anyways so they are going to be calling the physician for approvals whereas at the pharmacy things are done more rapidly and the pharmacist can take advantage of that interchangeability designation.

State-level pharmacy laws may affect interchangeability. The distribution of Semglee started this week, Casberg said, so the legal status of interchangeability will start to get tested.

Physicians are more likely to be comfortable with starting a patient on a biosimilar rather than switching them from a reference brand-name drug to a biosimilar. But Casberg said he expects some payers to start requiring “conversion” to a biosimilar. “Once they do, that is going to be a turning point,” he said.

In his presentation on Wednesday, Casberg shared data that showed the drop in the average sales price of the reference brand-name since the first biosimilar was approved, the number of biosimilars, and the market share of the biosimilars and the reference product. In some cases — notably, Remicade (infliximab) — the biosimilars haven’t cut into the reference product’s market share. Even so, the biosimilars seem to have had exerted some downward pressure on the price of Remicade. Casberg says price pressure without significant market share isn’t tenable over the long term.

“If biosimilars don’t end up being adopted eventually, manufacturers won’t make the products and we won’t see ASP (average sales price) decreases. We need biosimilars adoption to make this work.”