Humira’s patent blip
Humira, which had elevated itself to long-standing stardom on top of a massive intellectual property defense, was supposed to finally fall from the patent cliff last year. Instead, the best-selling drug of all time barely stumbled.
2023 was expected to be a 'watershed moment' for biosimilars, as eight lower-cost adalimumab versions launched referencing the branded drug that had amassed over $200 billion in revenue. In fact, many experts claimed that the future of biosimilars in the country would be shaped by the success or failure of these launches.
So imagine my surprise — while attending AAM’s Access! 2024 annual meeting — to hear so many speakers reference the spectacular failure of adalimumab biosims in 2023. At one year post-loss of exclusivity, the average biosimilar adoption rate is 22% — but adalimumab is sitting at under 2%.
Several reasons for the lack of uptake were discussion during the conference. Among them:
Lack of interchangeability for the first half of 2023: For starters, Humira works. Some prescribers are still hesitant to switch patients off an effective drug in favor of a drug that is not therapeutically identical. A survey conducted by Cardinal Health found that 60% of physicians would only feel “comfortable” prescribing biosimilars that are designated interchangeable.
Furthermore, the interchangeable designation means a biosim can be substituted for its reference product at the pharmacy, without approval from the prescribing physician.
Boehringer Ingelheim’s Cyltezo was the first FDA-approved interchangeable biosimilar to Humira, and it didn’t become commercially available until July 2023. Pfizer’s Abrilada nabbed the interchangeable designation as well, but not until October 2023.
PBMs are blocking access: Pharmacy benefit managers — currently enemy number in the U.S. dug pricing war — have been accused of denying patients coverage of lower-cost generics and biosimilars by creating drug formularies that favor more expensive drugs. The rebate system, in which PBMs generate revenue from drugmakers when list prices are high, has essentially blocked patient access to more affordable medications.
The problem with a story that involves a high profile drug like Humira, is that a biosimilar flop can turn a watershed moment into a cautionary tale. “Unfortunately, Humira has become the poster child for why we should leave biosimilars,” said Arunesh Verma, president and CEO at Cipla North America, during AAM Access!
But perhaps 2024 will help change the narrative. Cost Plus Drugs, Mark Cuban's online pharmacy, announced last year that plans to begin selling Coherus BioSciences' adalimumab biosimilar. (Cuban famously dropped a few f-bombs at last year’s AAM event, where he assailed PBMs during his fireside chat.)
Time will tell if biosimilars will get their watershed moment — but for now, the Humira river rages on.
—Karen Langhauser
Hope for metastatic pancreatic cancer patients
Metastatic pancreatic adenocarcinoma has long been known for its limited treatment options and dismal prognosis, with few advancements in therapies over the past decade. It ranks among the deadliest cancers globally, with approximately 90% of patients succumbing within five years of diagnosis. Over half of those diagnosed have either metastatic or locally advanced disease.
Earlier this week, the FDA approved Ipsen Biopharmaceuticals' Onivyde in combination with oxaliplatin, fluorouracil and leucovorin as a first-line treatment for metastatic pancreatic adenocarcinoma — marking a significant milestone in the management of this aggressive form of cancer.
Onivyde, a liposomal topoisomerase inhibitor, operates by disrupting DNA replication within cancer cells, leveraging the enhanced permeability and retention effect to penetrate tumor cells effectively. Ipsen's acquisition of the U.S. rights to the drug from Merrimack in 2017, along with Servier's international rights obtained through its acquisition of Shire's oncology business in 2018, have facilitated the global availability of this promising therapy.
With the new FDA approval as a combo first-line treatment, and approvals secured across major markets including the U.S., Europe and Asia as a second-line treatment in combination with fluorouracil and leucovorin, Onivyde now stands as a validated option for the treatment of adult patients with this deadly disease. — Andrea Corona
