Eye on Pharma: Celltrion Biosimilars Win Tenders; Oral Ustekinumab Device Passes Phase 1 Trial

Celltrion announced that 3 of its oncology biosimilar products have won tender contracts in France and Italy, and an experimental oral delivery device utilizing an ustekinumab biosimilar was successful in a phase 1 study.

Celltrion Wins Multiple Tenders

Celltrion won big in France and Italy, securing multiyear tender contracts for 3 of its oncology biosimilars (Herzuma, Truxima, Vegzelma), according to The Korea Herald. The contracts range from 2 to 4 years in France and for 2 to 4.5 years in Italy.

Several European countries, as well as Brazil, have tender systems. In these nations, pharmaceutical companies, both the originator and biosimilar companies, will compete on price in hopes that they will be chosen to be covered by public health plans of the country or region. The length of the contract and number of products chosen depend on the country. France’s system awards a single winner per tender, and Italy’s system allows for multiple winners in cases where more than 3 biosimilars are competing against the originator.

Herzuma is a trastuzumab biosimilar, Truxima is a rituximab biosimilar, and Vegzelma is a bevacizumab biosimilar. The products received marketing authorization from the European Medicines Agency in February 2018, February 2017, and August 2022, respectively.

“Since Vegzelma’s launch to Europe in 2022, Celltrion has achieved consecutive contracts with a diversified anti-cancer drug portfolio,” said Kim Dong-sik, Celltrion’s regional general manager in France. “Ensuring therapeutic efficacy and safety of our products, Celltrion will strengthen marketing strategies in a bid to reaching out to more European patients out there.”

In France, Herzuma and Truxima were chosen by 2 French public health agencies (Graps and GAULoYs) and Vegzelma was chosen by 3 agencies (Graps, Groupent Niort, and Groupment PharmSERA). The organizations together account for about 10% of France’s anticancer drug market. In Italy, all 3 biosimilars won tenders in the Friuli-Venezia Giulia and Sicily regions. The Italian win for Vegzelma also follows Celltrion’s previous wins in the nation’s Lombardy, Emilia Romagna, and Toscana regions in 2023.

Tender systems, particularly those that only award 1 winner, are often seen as controversial. Although they level the playing field between originators and biosimilars as well as brand name drugs and generics, they limit the number of viable competitors for several years and disincentivize companies from continuing to produce their products. Tenders can also create challenges during times of supply chain disruptions or drug shortages.

Oral Delivery Device Found Safe in Phase 1 Study

Rani Therapeutics shared positive topline results from a phase 1 study evaluating the safety of its oral drug delivery device (RaniPill) featuring an ustekinumab biosimilar developed by Celltrion (CT-P43) in healthy individuals.

The trial is the third successful phase 1 study assessing RaniPill technology. RT-111, the capsule plus CT-P43, is the first oral monoclonal antibody to achieve significant bioavailability in humans, according to Talat Imran, CEO of Rani Therapeutics.

“These data provide clinical validation of our ability to successfully transform an injectable large molecule into an oral pill. Specifically for this program, we believe RT-111 has the potential to offer a highly differentiated dosing regimen for patients with psoriasis compared to both injectable biologics and oral small molecules and peptides. The success of the Phase 1 study of RT-111 marks another significant milestone for the Rani team, as we diligently work towards making oral biologics a reality for the millions of patients living with autoimmune conditions,” said Imran in a statement.

Overall, 35 participants from a single center in Australia were included. The volunteers were administered RT-111 (n = 20), as either a 0.50 mg or 0.75 mg dose, or a 0.5 mg subcutaneously administered dose of reference ustekinumab (Stelara).

Participants in the RT-111 groups tolerated the treatment well without any serious adverse events. The incidence of antidrug antibodies was comparable between the 2 treatment arms. Additionally, participants in the RT-111 group did not experience difficulty swallowing the capsule, and capsule remnants passed without any issues.

This medication is being developed under a license and supply agreement between Rani and Celltrion, with Celltrion supplying the ustekinumab biosimilar exclusively for RT-111's development and commercialization. Following successful completion of a phase 1 clinical trial meeting primary end points, Celltrion holds the right of first negotiation to acquire worldwide rights to RT-111.