Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel
Teva Pharmaceuticals has announced a strategic collaboration with Klinge Biopharma and Formycon AG for the semi-exclusive commercialization of FYB203, a biosimilar candidate to Eylea® (aflibercept) in Europe (excluding Italy) and Israel. The product will be marketed under the brand name AHZANTIVE®, pending regulatory approval.
The collaboration leverages Teva's commercial experience in biosimilars and distribution network across Europe, combined with Formycon's expertise in biosimilar development. Under the agreement, Teva will lead commercialization efforts, while Klinge will receive milestone payments and revenue sharing.
The EMA's CHMP issued a positive recommendation for FYB203 in November 2024, with European Commission's decision expected in January 2025. The FDA has already approved the biosimilar in June 2024. Eylea®, used to treat neovascular age-related macular degeneration and other retinal diseases, generated global sales of approximately $9 billion in 2023, including $2.9 billion in the European market.
Teva Pharmaceuticals ha annunciato una collaborazione strategica con Klinge Biopharma e Formycon AG per la commercializzazione semi-esclusiva di FYB203, un candidato biosimilare a Eylea® (aflibercept) in Europa (esclusa l'Italia) e in Israele. Il prodotto sarà commercializzato con il nome di marca AHZANTIVE®, in attesa di approvazione regolatoria.
La collaborazione sfrutta l'esperienza commerciale di Teva nei biosimilari e la rete di distribuzione in tutta Europa, unita all'esperienza di Formycon nello sviluppo di biosimilari. Secondo l'accordo, Teva guiderà gli sforzi di commercializzazione, mentre Klinge riceverà pagamenti a milestone e condivisione dei ricavi.
Il CHMP dell'EMA ha emesso una raccomandazione positiva per FYB203 nel novembre 2024, con la decisione della Commissione Europea attesa a gennaio 2025. La FDA ha già approvato il biosimilare nel giugno 2024. Eylea®, utilizzato per trattare la degenerazione maculare neovascolare legata all'età e altre malattie retiniche, ha generato vendite globali di circa 9 miliardi di dollari nel 2023, inclusi 2,9 miliardi nel mercato europeo.
Teva Pharmaceuticals ha anunciado una colaboración estratégica con Klinge Biopharma y Formycon AG para la comercialización semiexclusiva de FYB203, un candidato biosimilar a Eylea® (aflibercept) en Europa (excluyendo Italia) e Israel. El producto se comercializará bajo la marca AHZANTIVE®, pendiente de aprobación regulatoria.
La colaboración aprovecha la experiencia comercial de Teva en biosimilares y su red de distribución en Europa, junto con la experiencia de Formycon en el desarrollo de biosimilares. Según el acuerdo, Teva liderará los esfuerzos de comercialización, mientras que Klinge recibirá pagos por hitos y participación en los ingresos.
El CHMP de la EMA emitió una recomendación positiva para FYB203 en noviembre de 2024, y se espera la decisión de la Comisión Europea en enero de 2025. La FDA ya ha aprobado el biosimilar en junio de 2024. Eylea®, utilizado para tratar la degeneración macular neovascular relacionada con la edad y otras enfermedades retinianas, generó ventas globales de aproximadamente 9 mil millones de dólares en 2023, incluidos 2.9 mil millones en el mercado europeo.
테바 제약이 Eylea® (아플리버셉트)의 바이오시밀러 후보인 FYB203의 반독점 상업화를 위해 Klinge Biopharma 및 Formycon AG와 전략적 협력관계를 발표했습니다. 이 제품은 규제 승인이 대기 중인 AHZANTIVE®라는 브랜드명으로 유럽(이탈리아 제외)과 이스라엘에서 판매될 예정입니다.
이번 협력은 유럽 전역의 바이오시밀러 및 유통 네트워크에 대한 테바의 상업적 경험과 Formycon의 바이오시밀러 개발 전문성을 결합하여 이루어졌습니다. 협정에 따라 테바가 상업화 노력을 주도하며, Klinge는 이정표 지급 및 수익 공유를 받게 됩니다.
EMA의 CHMP는 2024년 11월 FYB203에 대해 긍정적인 권고를 했으며, 유럽연합 집행위원회는 2025년 1월에 결정할 예정입니다. FDA는 이미 2024년 6월에 해당 바이오시밀러를 승인했습니다. Eylea®는 신생혈관성 노인성 황반퇴화 및 기타 망막 질환 치료에 사용되며, 2023년에는 전 세계적으로 약 90억 달러의 매출을 기록했으며, 그 중 29억 달러는 유럽 시장에서 발생했습니다.
Teva Pharmaceuticals a annoncé une collaboration stratégique avec Klinge Biopharma et Formycon AG pour la commercialisation semi-exclusive de FYB203, un candidat biosimilaire à Eylea® (aflibercept) en Europe (à l'exclusion de l'Italie) et en Israël. Le produit sera commercialisé sous le nom de marque AHZANTIVE®, en attente d'approbation réglementaire.
Cette collaboration s'appuie sur l'expérience commerciale de Teva dans les biosimilaires et son réseau de distribution à travers l'Europe, couplée à l'expertise de Formycon dans le développement de biosimilaires. Selon l'accord, Teva guidera les efforts de commercialisation, tandis que Klinge recevra des paiements d'étapes et un partage des revenus.
Le CHMP de l'EMA a émis une recommandation positive pour FYB203 en novembre 2024, et la décision de la Commission européenne est attendue en janvier 2025. La FDA a déjà approuvé le biosimilaire en juin 2024. Eylea®, utilisé pour traiter la dégénérescence maculaire néovasculaire liée à l'âge et d'autres maladies rétiniennes, a généré des ventes mondiales d'environ 9 milliards de dollars en 2023, dont 2,9 milliards sur le marché européen.
Teva Pharmaceuticals hat eine strategische Zusammenarbeit mit Klinge Biopharma und Formycon AG zur semi-exklusiven Vermarktung von FYB203, einem Biosimilar-Kandidaten zu Eylea® (Aflibercept) in Europa (außer Italien) und Israel angekündigt. Das Produkt wird unter dem Markennamen AHZANTIVE® stattfindend, wobei die regulatorische Genehmigung aussteht.
Die Zusammenarbeit nutzt Tevas kommerzielle Erfahrung im Bereich Biosimilars sowie das Vertriebsnetz in ganz Europa, ergänzt durch die Expertise von Formycon in der Entwicklung von Biosimilars. Im Rahmen der Vereinbarung wird Teva die Vermarktungsbemühungen leiten, während Klinge Meilensteinzahlungen und Umsatzbeteiligungen erhält.
Der CHMP der EMA gab im November 2024 eine positive Empfehlung für FYB203 ab, und eine Entscheidung der Europäischen Kommission wird im Januar 2025 erwartet. Die FDA hat das Biosimilar bereits im Juni 2024 genehmigt. Eylea®, das zur Behandlung von neovaskulärer altersbedingter Makuladegeneration und anderen Netzhauterkrankungen eingesetzt wird, erzielte im Jahr 2023 einen globalen Umsatz von etwa 9 Milliarden USD, darunter 2,9 Milliarden USD auf dem europäischen Markt.
- FDA approval already secured for FYB203 in June 2024
- Positive CHMP recommendation received, indicating likely EU approval
- Target drug Eylea® has substantial market size ($2.9B in Europe)
- Builds on existing successful partnership with Formycon for ranibizumab biosimilar
- Expands Teva's biosimilar portfolio in line with growth strategy
- Semi-exclusive rights only, excluding Italian market
- Revenue sharing arrangement with Klinge may impact profit margins
Insights
The strategic collaboration between Teva and Klinge/Formycon for FYB203 represents a significant market opportunity in the lucrative ophthalmology biosimilars space. With Eylea® generating
The commercial infrastructure synergies from Teva's existing Ranivisio®/Ongavia® distribution channels should enable rapid market penetration and cost-efficient commercialization. This vertical integration, combined with Formycon's supply chain management, suggests strong operational efficiency potential and higher margin capture.
The biosimilar market dynamics for aflibercept are highly favorable. With the European anti-VEGF market valued at nearly
The semi-exclusive commercialization rights, excluding Italy, still cover the most lucrative European markets. This deal aligns perfectly with Teva's Pivot to Growth strategy, expanding their biosimilar portfolio in a high-margin therapeutic area with established reimbursement pathways and growing demand due to aging populations.
The introduction of an Eylea® biosimilar holds substantial implications for healthcare systems across Europe. Biosimilars typically enter the market at
The positive CHMP recommendation and Formycon's track record in regulated markets suggest a smooth regulatory pathway. This collaboration could accelerate patient access to essential eye treatments while reducing healthcare system costs, particularly beneficial in markets with aging populations and growing healthcare expenditures.
- Klinge Biopharma GmbH (Klinge) holds the exclusive global commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®1
- Agreement builds on the proven and successful collaboration of commercialization of FYB201, Formycon's biosimilar to Lucentis®2 (ranibizumab) in Europe
- The partnership broadens Teva's biosimilars portfolio, in line with its Pivot to Growth strategy
TEL AVIV, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea® (aflibercept) in Europe, excluding Italy, and in Israel.
This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries. Klinge has in-licensed the exclusive global commercialization rights to FYB203 from Formycon.
Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE®3, subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product’s revenue.
Formycon is a leading, independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities.
Richard Daniell, Executive Vice President, European Commercial at Teva said: "We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio®4/Ongavia®5) in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve."
Commenting on the agreement, Nicola Mikulcik, CBO of Formycon, says, “With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio®/Ongavia®) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product.”
In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE® / Baiama®6. The European Commission's decision on approval is expected in the second half of January 2025.
Eylea® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea® achieved global sales of approximately USD 9 billion, including USD 2.9 billion in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector.
About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon shares are listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and are part of the selection index SDAX and TecDAX. Further information can be found at: https://www.formycon.com/
1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) Lucentis® is a registered trademark of Genentech Inc.
3) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4) Ranivisio® is a registered trademark of Bioeq AG
5) Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
6) Baiama® is a registered trademark of Klinge Biopharma GmbH
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to commercialize Formycon’s biosimilar product candidate to Eylea® (aflibercept) under the strategic partnership with Klinge, once European regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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