STADA Receives Final EMA Marketing Authorization in Europe for Movymia, a Biosimilar for Osteoporosis.
Background of EMA Approval and Demonstration of Equivalence
The European Medicines Agency (EMA) has granted final approval for Movymia, a biosimilar for the treatment of osteoporosis, developed by Gedeon Richter (RICHT) and marketed by STADA. This approval is based on data from a Phase 3 comparative clinical trial demonstrating the biological equivalence and safety of Movymia compared to the original drug, Forsteo, from Eli Lilly. Movymia, containing teriparatide, acts on the parathyroid hormone receptor 1 (PTHR1) receptor, a mechanism that directly activates osteoblasts, thereby promoting new bone formation. This differentiated mechanism is considered a strong alternative that can complement the limitations of existing bone resorption inhibitors, leading to a positive review by European regulatory authorities.
Price Competitiveness and Market Penetration Compared to the Original
Movymia is entering the market established by the original drug, Forsteo, and is expected to leverage its strong price competitiveness. Forsteo recorded global sales of approximately $1.6 billion in 2018, but with the expiration of its patent, it is facing strong pressure to lower prices due to the emergence of biosimilars. STADA plans to rapidly secure market share by offering a discounted price compared to the original drug, thereby reducing the financial burden on healthcare authorities in European countries. In particular, it is significant that Movymia provides a more affordable treatment option for patients who previously had difficulty accessing expensive bone-forming agents, thereby significantly improving healthcare access.
Partnership Structure and European Distribution Strategy
This commercialization is the result of a collaborative model achieved through a close licensing and distribution agreement between STADA and Gedeon Richter. The two companies signed an exclusive licensing agreement for Europe in October 2014, under which Gedeon Richter is responsible for product development and supply, and STADA is responsible for sales using its extensive European distribution network. Although the specific upfront payment and milestone amounts are not disclosed, the collaboration between the two companies has enabled simultaneous market entry upon the expiration of the original patent. STADA is launching the product under the Movymia brand, while Gedeon Richter is launching it under the Terrosa brand, employing a multi-brand strategy to maximize market share in Europe.
Growth of the European Osteoporosis Market and the Hurdle of Insurance Coverage
The European osteoporosis treatment market is expected to continue to grow from approximately $4.8 billion in 2025 to over $5.4 billion in 2030, driven by the aging population. Movymia has been launched at an opportune time to absorb the surge in patient demand, but the speed at which each country's healthcare authorities include it in insurance coverage (reimbursement) will be a key variable in the actual prescription activation phase. Due to varying cost-effectiveness assessment criteria in each European country, there may be some time difference in the final price negotiations. Nevertheless, with the trend of spreading biosimilar preference policies in line with the national fiscal austerity, the possibility of Movymia's early market success is highly positive.
From an investor's perspective, this European approval of Movymia represents an opportunity to erode the $1.6 billion Forsteo market (as of 2018) and drive the mid- to long-term biosimilar revenue growth of STADA and Gedeon Richter. The availability of Phase 3 comparative clinical trial data demonstrating equivalence to the original drug provides high clinical confidence in the prescription switching process. Industry professionals need to analyze the penetration path of competitively priced biosimilars in the approximately $4.8 billion European osteoporosis market and the success of country-specific price negotiation strategies. In the short term, the speed of initial inclusion in insurance coverage in each country will determine sales, and in the mid- to long-term, resolving patent disputes with the original company, Eli Lilly, and overcoming prescription barriers will be important milestones for the commercialization of subsequent pipeline products.
Source: EMA (ema)