Access Insights and Information Abound

Bruce Phelan discusses loss-of-exclusivity and biosimilar competition during his session at Access Insights 2023.

It is unbelievable to realize that we are already halfway through Q1 of 2024. It feels like yesterday that the Pharma Commerce team was in Orlando, Fla., attending the Access Insights Conference, an event dedicated to data-driven trends and strategies in drug access and commercialization that is co-hosted by IntegriChain and Blue Fin Group.

Although I touched on it in my December "Editor’s Note," it’s worth digging deeper. The conference—one in which Pharma Commerce was the preferred media partner and given exclusive access—covered a multitude of topics, such as:

• The fight for the dollar
• The pharmacy of the future
• Price transparency data in pharma
• A look at the 340B landscape
• Biosimilars and specialty generics impact on sites of care
• Price data transparency

Each session featured its share of spirited discussion, but a topic that has been continuing to gain momentum is that of biosimilars. In his session “How Biosimilars and Generics Will Find Success in the Various Sites of Care,” Bruce Phelan, a partner for IntegriChain’s consulting business, Blue Fin Group, presented a potential outlook on how these drugs will perform in the retail, specialty, and clinic spaces, while also presenting a preview of new biosimilars, specialty generics, and reference products.

Between 2023 and 2028, patent exclusivity for innovator products totaling $250 billion in sales is set to expire; combine that with the fact that biologics are considered the fastest-growing class of medicines in the US, and the door is wide open for exciting developments in the biosimilars space.

Regarding the former, a prime example is AbbVie’s branded form of adalimumab, Humira. The drug is used by many to treat inflammatory conditions such as rheumatoid arthritis and psoriatic arthritis, and had its exclusivity expire last year, which meant that adalimumab biosimilars are free to hit the market, as some already have. During the session, Phelan referenced Celltrion’s Yuflyma, which was approved by the FDA in May 2023 as the ninth adalimumab biosimilar, becoming commercially available two months later. However, as the industry also knows, timing is everything. Humira’s patent technically expired in 2016, but as a result of patent litigation, competing players in the space such as Amgen—whose biosimilar to Humira, Amjevita, was originally approved by the FDA that same year—had to end up waiting until January 2023 to launch.

Amjevita’s US 2023 Q2 and Q3 earnings were $19 million and $23 million, respectively, but on the international scale, sales totaled $131 million and $129 million for those same periods, respectively, providing some food for thought.

For continuing coverage of our “Conference Connect” series, you can always visit pharmaceuticalcommerce.com/latest-conference.