Teva Pharmaceutical Industries Limited announced a settlement and license agreement with Regeneron Pharmaceuticals that will allow the company to launch AVT06, a biosimilar to the eye‑disease drug Eylea, in the United States. The agreement sets a U.S. entry date for AVT06 in the fourth quarter of 2026, with the possibility of an earlier launch if certain conditions are met. The deal gives Teva a defined commercial window for the product and aligns with its “Pivot to Growth” strategy, which seeks to expand its biosimilar portfolio and move beyond its traditional generics business.
The U.S. launch of AVT06 is contingent on FDA approval. The FDA accepted the Biologics License Application for AVT06 on February 18, 2025, and the company is now awaiting review. While the agreement does not disclose the specific circumstances that would allow an earlier launch, the partnership provides a clear regulatory pathway and a timeline that Teva can plan around.
The Eylea market is a multi‑billion‑dollar opportunity. Regeneron reported U.S. sales of $5.97 billion for Eylea in 2024, and global sales reached $9.5 billion. Amgen’s Pavblu became the first U.S. Eylea biosimilar in October 2024, and several other aflibercept biosimilars have since received FDA approval. AVT06 will join this growing competitive landscape, offering Teva a chance to capture market share in a segment that is expected to expand as biologic patents expire and payers seek lower‑cost alternatives.
Teva’s financial performance in the fourth quarter of 2024 exceeded analyst expectations, but the company lowered its 2025 guidance. Adjusted earnings per share for the full year were projected at $2.35–$2.65, below the consensus estimate of $2.78, and the revenue outlook was trimmed. Management cited pricing pressure and competition—particularly in the multiple sclerosis and ophthalmology segments—as reasons for the more cautious outlook. The guidance downgrade contributed to a negative market reaction, underscoring the sensitivity of investors to Teva’s earnings trajectory.
The partnership with Regeneron gives Teva access to the manufacturer’s U.S. production and distribution capabilities, while Regeneron benefits from Teva’s established commercial network. The deal is a strategic step that leverages each company’s strengths: Regeneron’s expertise in developing and producing aflibercept and Teva’s global reach and experience in bringing biosimilars to market.
Robert Wessman, Chairman and CEO of Alvotech, said the settlement “provides a clear U.S. launch pathway for AVT06 and positions both companies to capitalize on the growing biosimilar market for retinal diseases.” Wessman added that the collaboration “strengthens our ability to deliver high‑quality, cost‑effective therapies to patients who need them.”
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