Ocrevus posted CHF 7.0 billion in global sales for 2025, a figure that makes every biosimilar developer in neurology recalculate its commercialization math. Teva clearly did the math and liked the result: the company has secured exclusive global rights to commercialize Polpharma Biologics’ ocrelizumab biosimilar candidate, covering both the intravenous and subcutaneous formulations, across the United States, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey. The deal structure is straightforward in its division of labor. Polpharma handles all development and manufacturing; Teva owns regulatory submissions and commercial execution once approvals land.
The strategic logic fits neatly inside Teva’s ongoing “Pivot to Growth” posture, which has leaned heavily on biosimilar partnerships rather than internal biologics discovery. The company launched SIMLANDI, an adalimumab biosimilar, in 2024 and secured FDA approval for its ustekinumab biosimilar SELARSDI in the same period, building a commercialization infrastructure for complex biologics that a deal like this one is designed to maximize. Licensing in a ready-to-develop asset rather than incubating one internally compresses capital risk while still giving Teva a presence in a large, durable MS franchise. Polpharma, for its part, gets global commercial reach it could not plausibly build on its own.
The competitive dynamics here matter because the ocrelizumab biosimilar race is still relatively early. No ocrelizumab biosimilar had received FDA or EMA approval as of early 2025, meaning the eventual market entrants will be setting reference prices against a brand that Roche has positioned as a growth driver through at least 2026. That first-to-market window carries outsized commercial value in a therapeutic class where neurologists develop strong prescribing habits and payer formulary decisions tend to lock in for extended contract cycles. The subcutaneous formulation adds a wrinkle: Roche markets the SC version in the U.S. separately as Ocrevus Zunovo, and a biosimilar that addresses both routes of administration broadens the addressable patient population considerably.
The single most consequential variable now is regulatory timeline: specifically, when Polpharma files its biologics license application with FDA and whether Teva can position the IV biosimilar for approval before competing candidates reach the same finish line. That filing date, not the deal announcement, is what determines whether this partnership becomes a category-defining launch or a crowded entry.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
