The inside story behind Samsung Bioepis’ European biosimilar takeover

Samsung Bioepis Co., Ltd. has begun direct commercialization of BYOOVIZ, its biosimilar to Lucentis (ranibizumab), across European markets following the full transfer of commercial rights from Biogen. The move signals a broader strategic pivot by Samsung Bioepis to exert more control over the distribution of its biosimilars and strengthen its standalone presence in the region.

The transition makes BYOOVIZ the fourth product that Samsung Bioepis is commercializing directly in Europe, joining EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab). The company confirmed that a pre-filled syringe (PFS) presentation of BYOOVIZ is expected to hit European markets in the second quarter of 2026, pending final regulatory formalities.

The company’s decision to internalize distribution is being viewed by analysts as a maturing signal of its go-to-market capabilities and growing confidence in product lifecycle management beyond development and regulatory approvals.

Why is Samsung Bioepis shifting toward direct commercialization of biosimilars in Europe?

The strategic decoupling from Biogen represents more than just a commercial realignment. Samsung Bioepis appears to be operationalizing a long-anticipated vertical integration strategy, effectively moving from a pure-play biosimilar developer to a fully integrated biopharmaceutical company with end-to-end control—from development through regulatory approval to sales.

The company’s Europe head, Antonio Rito, emphasized this trajectory, pointing to Samsung Bioepis’ track record with the direct launch of three other biosimilars in Europe over the past three years. Industry watchers interpret this as a quiet vote of confidence in the company’s commercial infrastructure, pricing strategy execution, and ability to engage payers and physicians directly—key competencies typically associated with more mature innovator or specialty pharma companies.

Samsung Bioepis may also be attempting to unlock better margins by eliminating revenue-sharing arrangements with legacy commercial partners like Biogen. This is particularly relevant given pricing pressure in the European biosimilar market, where discounts relative to originators often exceed 40 percent and reimbursement dynamics vary widely by country.

By directly managing pricing, negotiation, and promotional activities, Samsung Bioepis could better control brand perception, pricing tiers, and formulary inclusion—critical levers for sustaining market share as biosimilar competition intensifies.

What does BYOOVIZ’s expanded presentation format mean for uptake and positioning in 2026?

The anticipated arrival of the pre-filled syringe (PFS) format for BYOOVIZ in the second quarter of 2026 is a meaningful lifecycle development. Although the biosimilar has been approved in Europe since August 2021 in vial format, the PFS version offers convenience and standardization benefits for ophthalmologists, particularly in high-volume settings.

Ranibizumab biosimilars are primarily used in intravitreal injection treatment for wet age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal disorders. In these indications, consistency and reduced preparation time are key to procedural efficiency.

The PFS format could help Samsung Bioepis compete more effectively with both the reference product Lucentis and newer biosimilars that have already launched with syringe options in place. If the PFS version is priced competitively and integrated seamlessly into existing purchasing agreements with clinics and hospital groups, it may shift share in Samsung Bioepis’ favor.

Furthermore, this format could reduce medication preparation errors and enhance provider workflow—a subtle but non-trivial differentiator in an increasingly commoditized biosimilar space.

How does this impact Samsung Bioepis’ commercial model and competitive positioning?

The move to self-commercialize BYOOVIZ repositions Samsung Bioepis as not just a development engine but as a fully capable commercial player—at least in key biosimilar markets like Europe. For years, the company relied on licensing partnerships with global pharmaceutical companies to handle marketing and sales. This approach was necessary during the early growth phase when the company lacked brand equity, sales infrastructure, and payer relationships.

But now, with over a decade of regulatory approvals under its belt and multiple biosimilars in active commercial use, Samsung Bioepis appears ready to play offense. It can selectively absorb commercial functions in regions where it has built sufficient field force capabilities, market access teams, and distribution partnerships.

For rivals like Amgen, Sandoz, and Teva Pharmaceutical Industries that are also competing in the Lucentis biosimilar category, Samsung Bioepis’ verticalization could present new challenges. Its low-cost manufacturing advantage, proximity to key Asian and European markets, and investment in presentation differentiation may make it harder to dislodge once formulary access is secured.

Competitively, Samsung Bioepis is likely betting that tighter control of its European business can accelerate revenue recognition, improve market agility, and enhance responsiveness to post-launch feedback—a critical edge in rapidly evolving biosimilar markets.

What are the regulatory and institutional signals embedded in the BYOOVIZ timeline?

Regulatory bodies have already shown willingness to approve multiple ranibizumab biosimilars in both vial and syringe formats, suggesting that the European Medicines Agency (EMA) is keen to expand access to intravitreal therapies for retinal diseases. The CHMP’s positive opinion on BYOOVIZ’s PFS version in November 2025 confirms a relatively frictionless regulatory environment for format upgrades in this space, provided bioequivalence and device safety are demonstrated.

Institutional buyers—particularly in countries like Germany, France, and the Nordics—are also becoming more accepting of multiple biosimilar competitors coexisting in tenders or direct procurement frameworks. For Samsung Bioepis, this creates room to build deeper payer relationships, push for regional procurement wins, and tailor its pricing to national reimbursement dynamics.

However, the execution risk should not be understated. Switching away from Biogen means Samsung Bioepis must manage country-by-country distribution, regulatory pharmacovigilance, promotional compliance, and customer support without a co-commercial partner. This puts new pressure on the company’s European teams to scale up commercial operations efficiently while maintaining cost discipline.

What is the financial and capital allocation impact of the commercialization shift?

While Samsung Bioepis did not disclose financial terms related to the commercial rights reversion, it is likely that the company will now be entitled to a larger share of gross revenue from BYOOVIZ sales in Europe. This is consistent with its broader move toward financial self-reliance and margin expansion.

As Samsung Bioepis matures into a global biosimilar platform, retaining more of the commercialization value chain becomes strategically compelling. Assuming commercial execution does not lag, this shift could boost cash flows in its European segment—potentially reinvested into late-stage pipeline assets or new device-integrated biologics.

The move also signals disciplined capital allocation. Rather than expanding through large-scale acquisitions or launching novel biologics in highly competitive categories, Samsung Bioepis is focusing on deepening revenue from existing assets, extending product formats, and gaining distribution leverage in biosimilar strongholds.

Key takeaways on Samsung Bioepis’ European launch of BYOOVIZ and its strategic implications

• Samsung Bioepis has assumed full commercial control of BYOOVIZ in Europe, ending its co-commercialization arrangement with Biogen.

• The move expands Samsung Bioepis’ directly marketed European portfolio to four biosimilars, reinforcing its strategic autonomy.

• A pre-filled syringe version of BYOOVIZ is expected to launch in Q2 2026, offering procedural convenience and format differentiation.

• The shift supports margin expansion and vertical integration, as Samsung Bioepis moves closer to full biopharma lifecycle ownership.

• The PFS format could improve market uptake among ophthalmologists and compete more directly with syringe-based biosimilar rivals.

• Execution risk increases as Samsung Bioepis now manages pricing, promotion, and pharmacovigilance without Biogen’s infrastructure.

• The strategy highlights Samsung Bioepis’ maturing commercial capabilities and signals a broader trend toward internalization in the biosimilars space.

• Competitors may face increased pressure in pricing and payer negotiations if Samsung Bioepis executes effectively at scale.