The European Committee for Medicinal Products (CHMP) rejects Prestige Biopharma’s biosimilar referencing Herceptin; Prime Therapeutics’ plan to leverage biosimilars resulted in savings for patients; Samsung Biologics and AstraZeneca liquidated their joint venture (Archigen Biotech).
Prestige’s Trastuzumab Get Thumbs Down From CHMP
According to the European Medicine Agency’s European Committee for Medicinal Products (CHMP), Prestige Biopharma’s trastuzumab biosimilar (Tuznue; Hervelous) referencing Herceptin has not been recommended for approval.
Trastuzumab products are used to treat human epidermal growth factor receptor 2 (HER2)-positive breast and gastric cancers. The biosimilar was to be marketed as Hervelous in Belgium and Tuznue in the other European Union member nations.
The committee claimed that the manufacturing process of Tuznue used during clinical testing differed from the process required for commercial production. The CHMP concluded that the difference suggested that the studies did not provide enough evidence to show that the biosimilar candidate would be bioequivalent to the reference product.
The news comes after Prestige Biopharma announced positive phase 3 results of Tuznue’s use in patients with erb-B2 receptor tyrosine kinase 2-positive breast cancer in March 2022. Prestige’s manufacturing facility for Tuznue was also granted European Union Good Manufacturing Practices certification in February 2022.
Prestige Biopharma will be able to ask for re-examination of the recommendation refusal within 15 days of receiving the opinion.
Prime Therapeutics Sees Savings With Biosimilars
Prime Therapeutics said that its MedDrive program, its medical drug management program that leveraged biosimilars as a solution to patients’ high drug costs, cut expenses for its members by 26% in a single year.
The program launched in May 2021 and applied to Prime Therapeutics beneficiaries enrolled in 1 of its 23 Blue Plans. MedDrive helps patients reap the savings benefits from improving Prime’s contracts with manufacturers and recommending lower-cost alternatives to expensive brand-name specialty drugs, including biosimilars and generics. The program recommends biosimilars in 3 specialty drug categories, primarily for oncology.
“Drug prices continue to rise, which puts pressure both on insurers and the members they serve… MedDrive leverages the collective strengths of Blue Plans and Prime to put the brakes on medical drug spend without compromising patient care,” said Kelly McGrail-Pokuta, vice president of trade relations and strategy and chief trade relations officer at Prime Therapeutics.
The MedDrive program also utilizes advanced analytics and proactive consulting to clarify what factors are drivers for medical drug spending and predict changes that can lead to savings.
Samsung Biologics and AstraZeneca End Joint Venture
Samsung Biologics and AstraZeneca announced the end of their joint venture Archigen Biotech. The companies cited the development suspension of SAIT101, a rituximab biosimilar.
The move comes 2 months after Samsung Biologics’ board authorized the liquidation of Archigen Biotech, which was established in 2014. SAIT101 would have referenced Rituxan and would’ve been used to treat patients with certain types of lymphoma.
Samsung Biologics and AstraZeneca made the decision to halt SAIT101 production in the second half of 2020 after competitors, including Celltrion Healthcare, starting selling their own rituximab biosimilars.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.