Samsung Bioepis has announced a strategic partnership with Harrow (NASDAQ: HROW) that will grant the ophthalmology-focused company exclusive US commercial rights to two FDA-approved biosimilars targeting the $9 billion retinal disease treatment market. The agreement covers BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy), biosimilar versions of the blockbuster therapies LUCENTIS and EYLEA, respectively.
Partnership Details and Timeline
The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, expected by the end of 2025. In October 2024, Biogen terminated its 2019 Development and Commercialization Agreement with Samsung Bioepis for the US and Canada markets, creating the opportunity for Harrow to assume full commercialization responsibility.
"We are pleased to partner with Harrow, a leading eyecare pharmaceutical company with strong capabilities in commercialization of ophthalmic pharmaceutical products in the North American market," said Josh Sang Hyun Lee, Vice President and Business Development Team Leader at Samsung Bioepis.
Market Opportunity and Cost Advantages
The US retinal disease treatment market represents a significant opportunity, with anti-VEGF therapies like LUCENTIS and EYLEA generating over $4.2 billion in annual Medicare Part B spending in 2025. Harrow's biosimilars offer a compelling value proposition with 30-40% wholesale acquisition cost (WAC) reduction compared to their reference products.
Samsung Bioepis' Q1 2025 report noted that ophthalmology biosimilars achieved an average 81% market share within five years post-launch, indicating strong adoption potential. EYLEA currently holds a 36-40% market share, while LUCENTIS maintains 38-42% of the market.
Product Portfolio and Indications
BYOOVIZ (ranibizumab-nuna)
BYOOVIZ was approved by the FDA in September 2021 as the first ophthalmology biosimilar in the US and has been commercially available since June 2022. The VEGF inhibitor is indicated for treatment of:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Myopic Choroidal Neovascularization (mCNV)
OPUVIZ (aflibercept-yszy)
OPUVIZ received FDA approval in May 2024 for a broader range of indications, including:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
Financial Impact and Growth Projections
Harrow's recent financial performance demonstrates strong growth momentum, with a 53.5% revenue increase in the last twelve months and a gross margin of 74.5%. Q1 2025 revenue reached $47.8 million, representing a 38% year-over-year increase.
The acquisition of BYOOVIZ and OPUVIZ is expected to drive revenue past $280 million in 2025. Analysts from Cantor Fitzgerald, H.C. Wainwright, and William Blair have assigned price targets ranging from $60 to $62, with "Buy" or "Overweight" ratings, reflecting confidence in Harrow's market capture potential.
Industry projections suggest Harrow could capture 15-20% of the US retinal disease market within three years, potentially generating $1.35-$1.8 billion in annual revenue while driving EBITDA margins above 30%.
Safety Considerations
Both biosimilars carry similar safety profiles to their reference products. Key warnings include potential risks of endophthalmitis and retinal detachments following intravitreal injections, increases in intraocular pressure, and potential arterial thromboembolic events associated with VEGF inhibitors.
The most common adverse reactions for BYOOVIZ include conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. OPUVIZ's most frequent adverse reactions (≥5%) include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Strategic Positioning
Samsung Bioepis emphasized its commitment to expanding access to affordable biologic medicines. "Samsung Bioepis remains committed to expanding access and widening treatment options for healthcare systems, healthcare professionals, and patients, by providing affordable and high-quality biologic medicines around the world," Lee stated.
The partnership positions Harrow to leverage its existing commercial infrastructure and network of retina specialists to accelerate biosimilar adoption in the ophthalmology market, potentially disrupting the dominance of high-cost reference therapies.
