Daratumumab, isatuximab (CD38 drugs)

From Nigeria press release

  • Darzalex is a cold-chain product and is not registered in Nigeria.
Isn’t it concerning that Dara is not available for multiple myeloma in a country of 240 million people?
 
Jaybee00 said:
Russian Dara biosimilar—should be released soon.

biocad.ru

Даратумиа

BIOCAD — международная инновационная биотехнологическая компания полного цикла
biocad.ru biocad.ru
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Seems like it might already have been approved in Russia. There are two other biosimilars on the way as well.
www.pearceip.law

BIOCAD Obtains Approval of First Daratumumab Biosimilar | Pearce IP

On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab
www.pearceip.law www.pearceip.law

I don’t fully understand when the patent for Dara expires where, but it seems like it’s probably relatively soon based on the activities by competitors.
 
Bad news. My information regarding the patent expirations wasn’t up to date. I thought the expiration date was March 2026 for IV and 2030 for FASPRO, but it seems the patents have been extended.

IV expires in 2029.
FASPRO (SC) in 2035.

Gemini Pro:

Core Patent Expiration Timeline​

The loss of exclusivity for Darzalex will happen in staggered phases depending on the region and the specific formulation of the drug (Intravenous vs. Subcutaneous).

  • United States (Intravenous): The core composition-of-matter patent protecting the original IV formulation of Darzalex (US Patent 7,829,673, owned by Genmab) has a Patent Term Extension that pushes its final expiration to May 22, 2029. Biosimilar entry for the IV version in the US is heavily constrained until this date.

  • Europe (Intravenous): While standard regulatory market protection expires sooner, Supplementary Protection Certificates (SPCs) attached to the core European patent (EP2567976) will block biosimilar entry in the EU until March 2031 (and up to 2032 in some specific European jurisdictions).
  • Japan (Intravenous): The relevant Genmab-owned patents in Japan are also set to expire in 2029.

The "Faspro" Strategy: Extending Exclusivity to 2035​

The most critical nuance in the Darzalex patent story is the introduction of Darzalex Faspro (daratumumab and hyaluronidase-fihj), the subcutaneous (injected under the skin) version of the drug.

  • Distinct Patent Portfolio: While Genmab owns the underlying patents for the daratumumab molecule (expiring 2029–2031), Johnson & Johnson holds a separate, highly defensive patent portfolio covering the subcutaneous formulation.
  • Extended Timeline: The patents protecting Darzalex Faspro do not expire until the mid-2030s (specifically 2035).

  • Market Impact: J&J has aggressively and successfully transitioned the vast majority of Darzalex patients away from the hours-long IV infusion to the minutes-long Faspro injection. Even when the IV patents expire in 2029, any biosimilar competitors will only be able to launch IV versions. J&J's subcutaneous market share is largely protected from biosimilar competition until 2035.

Regulatory Exclusivities vs. Patents​

As a biologic treating rare conditions like multiple myeloma and light-chain amyloidosis, Darzalex was granted multiple layers of regulatory protection, including:

  • Reference Product Exclusivity (RPE): 12 years in the US and 10 years in the EU.
  • Orphan Drug Exclusivity (ODE): 7 years in the US for specific indications.
While these regulatory periods dictate when a competitor can file for a biosimilar, the hard patent dates (2029 in the US, 2031 in the EU) are the ultimate bottlenecks. A competitor could hypothetically get a biosimilar approved by the FDA before 2029, but patent law prevents them from actually commercializing and selling it until the May 2029 patent lapse.
Click to expand...
 
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