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Biosimilar Business Recap: CHMP Rejects Herceptin Biosimilar; Prime Therapeutics Biosimilar Success; Archigen Biotech Liquidation


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.

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