Generics Companies’ Positioning in Biosimilar Industry in H1 2026

Generics companies signed the two largest biosimilar transactions of H1 2026, but as of September 2026, there is still only one generics company, Sandoz, within the top five leaders by market share. This chapter of Alira Health’s 2026 Global Biosimilars Market Midyear Review explores how these leaders have made moves to manage their biosimilars business and how generics companies have positioned themselves in biosimilars.

In previous years, large pharmaceutical companies that funded biosimilar programs early found that a business built to defend premium pricing during exclusivity was difficult to operate alongside one that exists because exclusivity has ended and sold:

• Merck & Co. placed its biosimilar interests into Organon in 2021.
• Biogen sold its holding in Samsung Bioepis to Samsung in 2022.
• Viatris sold its biosimilars business to Biocon in the same year.
• Novartis separated Sandoz as a standalone company in October 2023.
• Boehringer Ingelheim retreated from biosimilars outside the United States (US) and now competes through a single molecule.

Sun Pharmaceutical Industries expects its acquisition of Organon to take the combined group to approximately the seventh-largest biosimilar position worldwide. The six positions ahead of it belong to Sandoz, Pfizer, Amgen, Celltrion, Biocon Biologics, and Samsung Bioepis.

Effective January 1, 2026, Pfizer moved its remaining biosimilar business out of Specialty Care and Oncology into a new Global Hospital and Biosimilars division, grouped with off-patent branded and generic sterile injectables. However, Pfizer’s development pipeline carries new molecular entities and product enhancements and no biosimilar candidates. Pfizer now runs its eight marketed biosimilars in the same operating model as its established products business, which places it outside the competition for the next wave of molecules while it continues to earn from the last one.

Amgen has reported biosimilar sales of approximately $3 billion in 2025, an increase of approximately 37% over 2024. PAVBLU^® contributed approximately $700 million in its first full year as the only aflibercept biosimilar on the US market. Amgen has completed enrollment in a comparative clinical study of ABP 206 against Opdivo^®, is enrolling a Phase III study of ABP 692 against Ocrevus^®, and is working on a pembrolizumab candidate. These can be three of the largest biosimilar opportunities of the coming decade, and Amgen is pursuing them through its own development organization and plants, while simultaneously defending Prolia^® and Xgeva^® against denosumab biosimilars.

The three remaining leaders, Celltrion, Biocon Biologics, and Samsung Bioepis, are integrated specialists that own their development capability and their manufacturing capacity, with Celltrion and Biocon Biologics also selling through their own commercial organizations. Biocon Biologics, a biosimilar developer, reached a leader position by buying the Viatris biosimilars business in 2022, acquiring commercial reach.

In contrast, several dedicated biosimilar players, including Bio-Thera Solutions, Shanghai Henlius Biotech, Alvotech, and Kashiv BioSciences, were quite active in the space despite not ranking among the market-share leaders. Rather than commercializing their products directly, they rely on bigger commercial partners such as Accord BioPharma, STADA, and Amneal Pharmaceuticals to reach patients.

A licensed and contract-manufactured product carries two deductions to the licensee’s own margin:

• A royalty goes to the developer, normally agreed as a percentage of net sales.
• A manufacturing margin goes to the contract development and manufacturing organization (CDMO), embedded in cost of goods as an amount per unit.

Price erosion, in a biosimilar space with several competitors, compresses the pool from which both deductions are taken. The two deductions do not respond to that margin compression in the same way. The royalty falls automatically with price, so the developer carries a proportionate share of the erosion. The per-unit manufacturing cost does not fall with price, so cost of goods rises as a share of revenue, which can place increasing pressure on the economics of the developer’s manufacturing arrangement and can lead to a renegotiation of the royalty when the agreement comes up for renewal.

When we look at the way generics companies have positioned themselves in biosimilars to date, we see five distinct routes, set out below, with the earliest tell-tale acquisition completed four years before the transactions of H1 2026:

Route 1: Full internalization of development and manufacturing

In 2022, Fresenius Kabi acquired development capability and manufacturing capacity in a single transaction, purchasing 55% of mAbxience from Insud Pharma for €495 million upfront plus commercial and development milestones, with a put and call arrangement over the remaining 45%. Fresenius Kabi described the target at the time as two businesses in one company, a biosimilar developer with its own pipeline and a biologics CDMO running drug substance facilities in Spain and Argentina. They set out the rationale as an end-to-end vertically integrated footprint with cost synergies against the existing Fresenius Kabi biosimilar portfolio. Sandoz and Amneal Pharmaceuticals arrived at versions of the same conclusion three and four years later, at higher prices and in a market carrying more competitors on each molecule. Fresenius Kabi is therefore the longest-running test of whether internalization delivers what its buyers expect, although the group has not disclosed enough on mAbxience for the market to evaluate the outcome.