Amneal Submits BLA for Potential Xolair Biosimilar

A potential new biosimilar to Xolair (omalizumab) has had its Biologics License Application (BLA) submitted to the FDA by Amneal Pharmaceuticals and Kashiv BioSciences, expanding more affordable drug options for those with asthma, food allergies and other conditions, according to an announcement released today.

Xolair, developed by Genentech and Novartis, is a humanized monoclonal antibody that works by binding to immunoglobulin E (IgE), a key driver in allergic responses. Approved in multiple therapeutic areas, Xolair is indicated for patients as young as one year old with IgE-mediated food allergies, children as young as six with moderate to severe persistent asthma and adults with chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic spontaneous urticaria (CSU).

These conditions can be burdensome, limiting quality of life and, in some cases, leading to life-threatening complications if not effectively treated.

Amneal submits a BLA for a new Xolair biosimilar, promising affordable treatment options for asthma and allergies, enhancing patient access and competition.

Asthma, one of the main conditions treated by omalizumab, affects more than 25 million people in the U.S., according to the CDC. Severe cases often remain uncontrolled by standard therapies such as inhaled corticosteroids, leaving patients with persistent symptoms and frequent exacerbations. CRSwNP is another difficult-to-manage disease characterized by recurring growths in the nasal cavity that cause congestion, loss of smell and breathing difficulties. Food allergies and CSU, which involve hives and swelling, further highlight the broad demand for effective biologic therapies.

For many patients, omalizumab provides relief when other options fail, but the high cost of treatment has limited accessibility.

For example, data shows that patients with commercial insurance may pay nothing out of pocket, but those who do often face monthly costs ranging from $5 to $1,475 after meeting deductibles. Medicare beneficiaries see similar variation, with most paying between $5 and $868 monthly. For Medicaid enrollees, most patients pay nothing, while uninsured patients can rely on financial assistance programs.

Even with these programs, affordability remains a major concern. U.S. sales of Xolair totaled $4.1 billion in the 12 months ending July 2025, displaying both its market size and its importance as a target for biosimilar development.

Biosimilars, which are similar to approved biologic drugs but typically priced lower, have the potential to reduce costs across the healthcare system.

According to a 2024 study in JAMA Health Network, biosimilars typically launch at prices 15% to 35% lower than their reference products, and their entry often pressures brand-name manufacturers to offer additional discounts. For patients, this competition can translate into reduced out-of-pocket expenses and broader treatment access.

The Xolair biosimilar space is still new.

In March 2025, the FDA approved Omlyclo (omalizumab-igec), developed by South Korea–based Celltrion, as the first interchangeable biosimilar to Xolair. Omlyclo is indicated for the same range of conditions, including asthma, CRSwNP, CSU and IgE-mediated food allergy. It is administered as a subcutaneous injection. However, U.S. patients may need to wait until September 2026 for Omlyclo’s commercial launch, according to reports by its manufacturer.

In the meantime, Celltrion announced on September 19, 2025, the drug will become available in Norway and eventually across Europe, though the exact timeline of the release remains unclear.

Amneal’s potential option could change the landscape. While the product’s name has not yet been disclosed, its early BLA filing accelerated the company’s development timeline and recorded a $22.5 million research and development milestone charge in the third quarter of 2025.

Amneal’s Chief Commercial Officer Andy Boyer stressed the significance of the filing, noting that biosimilars are poised to be “a key growth driver” for the company, with as many as five additional biosimilar launches expected between 2026 and 2027.

Kashiv BioSciences, Amneal’s partner, has already developed FDA-approved biosimilars such as Releuko (filgrastim-ayow) and Fylnetra (pegfilgrastim-pbbk).

Kashiv’s CEO, Sandeep Athalye, M.D., highlighted the importance of bringing affordable biologics to market, pointing to their organization’s role as one of the few U.S.-based firms with both manufacturing and marketing capabilities for multiple biosimilars.

If approved, Amneal’s biosimilar would become another U.S.-marketed alternative to Xolair, alongside its competitor Omlyclo. The availability of multiple options could intensify pricing competition and accelerate the pace at which payers, providers and patients adopt biosimilars.

With Xolair generating billions annually and treating a range of chronic and costly conditions, the impact on both the healthcare system and patient affordability could be significant.