Probing pharma-sponsored testing
This week, BioMarin revealed that it had received a subpoena from the U.S. Department of Justice seeking information about the company's sponsored testing programs related to two older enzyme replacement therapies for rare conditions.
The disclosure was buried on page 48 of BioMarin's recent SEC filing (but not deep enough for journalists not to find it, apparently) and was light on details. According to BioMarin, the DOJ requested that the company produce "certain documents" regarding its sponsored testing program for the drugs Vimizim and Naglazyme.
Pharma-sponsored testing programs, especially genetic testing programs, have become more prevalent with the advent of personalized medicines and targeted therapies.
California-based BioMarin has been active in the practice, participating in several collaborative programs offering sponsored, no-charge genetic testing in areas such as epilepsy and skeletal dysplasia.
In many ways, the programs are a win-win: For patients, they help increase awareness and access to testing options. In exchange, sponsoring companies get access to data that they can use to recruit patients for clinical trials, grow awareness of new therapies, or develop new diagnostic tests.
HIPAA doesn’t allow pharma companies to get identifiable protected health information, so results must be ‘de-identified’ — meaning stripped of personal info.
However, as pointed out by a recent commentary posted in the Cleveland Clinic Journal of Medicine, there is not a lot of transparency in terms of the downsides of these arrangements. Lacking this readily available info on the disadvantages, clinicians often struggle to advise patients who are considering participating in the sponsored programs.
The DOJ probe raises transparency questions about the broader industry practice of sponsored testing. Depending on how it shakes out, it could call into question the legitimacy of manufacturer-sponsored testing programs. There isn’t a lot of info available at the moment, but as details about the BioMarin inquiry come to light, it’s going to be an interesting story to follow. —Karen Langhauser
FDA approves Alvotech, Teva Humira biosim
Alvotech, together with Teva Pharmaceuticals' U.S. division, scored a win this week when the FDA approved their drug, Simlandi, as an interchangeable biosimilar to Humira.
Simlandi is the first high-concentration, citrate-free biosimilar interchangeable with Humira, underscoring its unique position in the market. Given that the high-concentration form of adalimumab accounts for nearly 88% of prescriptions, Simlandi has significant potential for patient impact.
The journey to approval was fraught with challenges, including legal battles and regulatory hurdles. Despite facing lawsuits and multiple rejections from the FDA due to manufacturing issues, Alvotech persevered, ultimately securing the nod.
As one of the world’s best-selling drugs, AbbVie’s Humira has played a pivotal role in advancing treatment options for patients with a wide range of autoimmune diseases, with 10 U.S. indications and 14 worldwide. However, its high cost has been a point of contention, highlighting the need for more affordable alternatives to ensure broader patient access.
In the U.S., the annual cost of Humira can reach approximately $77,000, with patient out-of-pocket expenses differing widely based on insurance. Conversely, in the EU, where adalimumab biosimilars have been on the market since 2018, the biosims have captured over half the market. This shift has not only reduced costs for patients opting for biosimilars but also prompted price reductions for Humira itself. For instance, in the Netherlands, the introduction of biosimilars led to discounts of up to 89% on the branded medication.
This week’s approval of Simlandi and the introduction of other biosimilars to the market, will continue to help to close this accessibility gap. — Andrea Corona
