Eye on Pharma: Europe and MENA Region See Expanding Biosimilar Pipelines

In 2025, European, Asian, and African biosimilar markets saw major developments as Celltrion announced updates for several biosimilars in development, STADA Arzneimittel saw progress for its denosumab biosimilars, and Polpharma Biologics partnered with MS Pharma to commercialize 3 biosimilars in emerging markets.

Major advancements in biosimilars emerge in Europe and Middle East and North Africa (MENA) region, enhancing patient access and affordability in critical therapeutic areas.

Celltrion Updates on Omalizumab, Secukinumab, and Daratumumab

Celltrion announced several milestones at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, underscoring its growing dermatology and immunology portfolio. Omlyclo, the first and only omalizumab biosimilar approved in Europe, will launch in Norway, with further rollouts across the region. The company also presented global Phase III results for Omlyclo in chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, showing comparable efficacy and safety to the reference product during both treatment and observation periods. Experts emphasized the biosimilar’s significance in expanding patient access and improving quality of life for those with immuno-dermatologic conditions.

In addition, Celltrion highlighted positive early-stage results for CT-P55, a proposed secukinumab biosimilar, which demonstrated similarity in efficacy and safety in healthy subjects. With Omlyclo, Celltrion’s dermatology portfolio now includes 5 products: infliximab, adalimumab, ustekinumab, and omalizumab biosimilars.

Separately, Celltrion received European Medicines Agency approval to begin a phase 3 trial of CT-P44, a biosimilar candidate referencing daratumumab and hyaluronidase (Darzalex Faspro), in relapsed or refractory multiple myeloma. The randomized, 2-year trial will evaluate efficacy and safety in combination with lenalidomide and dexamethasone.

CHMP Opinion for STADA Denosumab Biosimilars

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of STADA Arzneimittel’s denosumab biosimilar candidates Kefdensis and Zvogra, referencing Amgen’s Prolia and Xgeva, respectively.³ The recommendations cover all indications of the reference products, including osteoporosis and fracture prevention for Kefdensis and skeletal-related event prevention in oncology and treatment of giant cell tumor of bone for Zvogra. If approved by the European Commission, the products would mark STADA’s tenth approved biosimilar in Europe, complementing its teriparatide, bevacizumab, epoetin, adalimumab, tocilizumab, ustekinumab, aflibercept, and ranibizumab biosimilars.

Denosumab biosimilar entry is anticipated following the European Union exclusivity expiry in late 2025, with the market valued at approximately €1 billion. Increased competition is expected to expand access and reduce overall treatment costs. Ian Henshaw, STADA’s global specialty head, stated that the CHMP opinion “marks a significant milestone in broadening access to a blockbuster biologic medicine for bone conditions affecting millions of people in Europe.”

The denosumab biosimilars, also known as AVT03, were developed and manufactured by Alvotech, which partnered with STADA for commercialization in Europe, Central Asia, and the Middle East. Specialty, including biosimilars, was STADA’s fastest-growing segment in the first half of 2025, with revenues rising 18% to €486 million.

Polpharma Biologics and MS Pharma Partner for MENA Region

Polpharma Biologics has entered into licensing agreements with MS Pharma for the commercialization of 3 biosimilar candidates—vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019)—across the Middle East and North Africa (MENA) region.⁴ Under the deal, MS Pharma will handle registration, marketing, and distribution, while Polpharma Biologics will oversee development, manufacturing, and supply. Fill-and-finish activities will be localized to MS Pharma’s new biologics facility in Saudi Arabia.

The biosimilars target high-need therapeutic areas: vedolizumab for ulcerative colitis and Crohn disease, ocrelizumab for multiple sclerosis, and guselkumab for moderate to severe plaque psoriasis and psoriatic arthritis. According to the companies, these partnerships are expected to broaden access to affordable biologics in gastroenterology, neurology, and dermatology.

“Expanding our biosimilar portfolio in high-need therapeutic areas…is a strategic priority,” said MS Pharma CEO Kalle Känd, noting the collaboration reinforces the company’s regional leadership. Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics, added that MS Pharma’s “deep regional expertise and strong commercial network” make it an ideal partner to improve patient access.

The agreement builds on an established relationship between the companies and supports efforts to strengthen biologics manufacturing capacity and health care sustainability in the MENA region.

References

1. Celltrion announces commercial availability of Omlyclo across Europe at EADV 2025. News release. Celltrion. September 18, 2025. Accessed September 23, 2025. https://www.businesswire.com/news/home/20250903480207/en/Celltrion-Announces-Commercial-Availability-of-Omlyclo-Across-Europe-at-EADV-2025

2. Kim J-h. Celltrion gets EMA nod for phase 3 trial of Darzalex biosimilar. Korea Biomedical Review. September 1, 2025. Accessed September 22, 2025. https://www.koreabiomed.com/news/articleView.html

3. STADA further builds its bone-health and oncology offering with positive CHMP opinion on denosumab biosimilars. News release. STADA Arzneimittel. September 19, 2025. Accessed September 22, 2025. https://www.stada.com/blog/posts/2025/september/stada-further-builds-its-bone-health-and-oncology-offering-with-positive-chmp-opinion-on-denosumab-biosimilars

4. Polpharma Biologics and MS Pharma sign licensing agreements for proposed vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars. News release. Polpharma Biologics. September 2, 2025. Accessed September 22, 2025. https://www.biospace.com/press-releases/polpharma-biologics-and-ms-pharma-sign-licensing-agreements-for-proposed-vedolizumab-pb016-ocrelizumab-pb018-and-guselkumab-pb019-biosimilars