On July 22, Samsung Bioepis announced that it has received marketing approval by the FDA for its eculizumab biosimilar Epysqli®. The vowel-challenged brand name, which also has an interesting nonproprietary suffix (eculizumab-aagh), is the second approved biosimilar for the reference product Solaris®.
The approval for this C5 complement protein inhibitor covers the following indications:
- Treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
- Treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibitor complement-medicated thrombolytic microangiopathy
Samsung Bioepis indicated that the biosimilar is not indicated for the treatment of patients with Shiga toxin E. coli–related hemolytic uremic syndrome (i.e., Epysqli has the same indications as the reference product).
Epysqli is approved for use in the EU. Samsung Bioepis has not yet named a commercialization partner for this product. Amgen, which obtained approval in late May for its product Bkemv® signed an agreement with Alexion to launch in May 2025. Samsung has not signed an agreement with Alexion, and a heated litigation battle is still underway, according to Big Molecule Watch.
In Other Biosimilar News
Boehringer Ingelheim’s new deal with GoodRx offers its unbranded adalimumab biosimilar (adalimumab-adbm) at a 92% discount to anyone, regardless of insurance status, through more than 70,000 US pharmacies. The new discount (resulting in a price of $550 per two-pack prescription) applies to both the low-concentration and high-concentration formulations.
“Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease,” said Chris Marsh, Senior Vice President of Value and Access at Boehringer Ingelheim in its press release. “Partnering with GoodRx to offer our biosimilar Adalimumab-adbm at a low price to these patients helps us deliver on our commitment to lowering financial barriers and improving access to critical treatments.”
However, it is unsure who exactly this helps. Patients with no insurance (or are underinsured) are unlikely to pay $550 per prescription for long. Also, commercial patients will have access to copayment coupons, reducing prescription costs drastically, through Boerhinger’s patient services hub. Ordinarily, adalimumab is dispensed through specialty pharmacies, not community pharmacies; the logistics of a dispensing network will need to be worked out if patients were to receive the injectable at their local pharmacy.
(This post was revised July 23 with a correction regarding Samsung Bioepsis’ commercialization partner for Epysqli.)
