Biosimilars and Biobetters

mAbxience and Sandoz are targeting a $5.7 billion market with a proposed emicizumab biosimilar for hemophilia A.

TSY-110 could become the first biosimilar rival to Roche's ado-trastuzumab emtansine (Kadcyla), a $2.5 billion HER2 breast cancer therapy.

FDA's 2025–2026 guidance changes would substantially streamline biosimilar development, including by reducing comparative efficacy and switching-study requirements. Here's what's confirmed, what industry has criticized about the existing pathway, and what's still unresolved.

Shanghai Henlius Biotech has entered a strategic collaboration with Sandoz covering up to 10 proposed monoclonal antibody and antibody-drug conjugate biosimilar assets, deepening the companies' existing oncology biosimilars partnership with initial deals worth up to $322 million.

Polpharma Biologics and Fresenius Kabi announced that the FDA and EMA have accepted for review PB016, a proposed biosimilar to Takeda's Entyvio (vedolizumab), with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa.

Teva Pharmaceuticals has entered a global licensing agreement with Polpharma Biologics for exclusive commercialization rights to a proposed biosimilar of Ocrevus (ocrelizumab), the CD20-targeted monoclonal antibody used to treat relapsing and primary progressive multiple sclerosis.

FDA’s approval of Immgolis and Immgolis Intri introduces the first golimumab biosimilars for rheumatoid arthritis and ulcerative colitis in the United States.

Henlius and Organon have secured approval in Europe for its pertuzumab (POHERDY) biosimilar, expanding biosimilar access for HER2-positive breast cancer treatment across oncology settings.

Amneal’s acquisition of Kashiv is expected to advance biosimilar development capacity, which in turn would support access to biologics amid an anticipated wave of loss-of-exclusivity patents globally.

FDA approval of a denosumab (Prolia) biosimilar and dual filing acceptances by FDA and EMA for an omalizumab (Xolair) biosimilar candidate from Teva signal increasing competition in the biosimilar markets as well as expanded access for allergy and immunology patients.

A look at interchangeable biosimilars gaining FDA approval, the growth in global partnerships, and the rising biologics patent cliff.

The partnership expands patient access in MENA by localizing biosimilar manufacturing and distribution for gastro, neuro, and dermatology treatments.

The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.

Under the licensing agreement, the proposed biosimilar candidate, PolyPB016, will be developed and manufactured by Polpharma Biologics and commercialized by Fresenius Kabi.

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.

As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.

The bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.

Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.

Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.

Omlyclo (omalizumab-igec) was approved to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and certain food allergies.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.