Radar on Drug Benefits

As biologics research and development becomes more granular, biosimilars may wind up both less useful and profitable than boosters of the drug category once thought. According to experts, the first wave of biologic patent expiry is almost over — and a new set of expirations starting in 2024 will determine whether biosimilars will have as big an impact in the U.S. as they have in the European Union.

There has been a large number of biosimilar approvals in recent years, according to business intelligence firm GlobalData. The EU “experienced this biosimilar wave ahead of regions such as the US and Asia-Pacific because the EU created the first biosimilar-specific approval pathway,” according to Quentin Horgan, GlobalData’s senior drugs database analyst. Approvals of biosimilars have slowed down in recent years.

✦ Walgreens Boots Alliance Inc. will spend $970 million to acquire a 71% stake in Shields Health Solutions, a specialty pharmacy company. Shields contracts with health systems and hospitals to build and operate on-site specialty pharmacies. The transaction builds on a minority investment that Walgreens made in July 2019. According to a Sept. 21 press release, Shields “represent[s] more than 1 million specialty patients across more than 30 disease states, with more than 70 health system partners nationwide.”

✦ Inovalon Holdings Inc. struck a deal with CorEvitas LLC to gain access to CorEvitas’ analytics on rheumatoid arthritis and psoriasis. Inovalon will combine the data from the CorEvitas platform with its larger chronic condition database. According to a Sept. 21 press release on the deal, “insights made possible through these analytics can advance clinical development, inform trial design and recruitment, substantiate value narratives, and inform patient-specific intervention plans.”

Earlier this month, the FDA approved a drug that the manufacturer touts as “the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.” Drug benefits experts say it could be a good option for patients who have previously been on extended-release drugs for the schizophrenia — with careful monitoring — and will likely be covered similar to existing long-acting treatments.

The drug is called Invega Hafyera (six-month paliperidone palmitate), a product produced by Janssen Pharmaceuticals, Inc., a Johnson & Johnson unit. It received FDA clearance on Sept. 1 after a randomized, double-blind, non-inferiority Phase III global study that enrolled 702 adults living with schizophrenia from 20 countries, which found that 92.5% of patients treated with Invega Hafyera were relapse-free at 12 months.

This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.

Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.