Omalizumab (Xolair) Biosimilars & Biosuperiors Pipeline Review

Omalizumab (Xolair) Biosimilars & Biosuperiors Pipeline Review

Reference Product: Xolair

Target: Immunoglobulin E (IgE)

Product Category: Antibody

This product provides basic information on approved drugs and drug candidates in research and development as biosimilar or biosuperior antibodies of Xolair (omalizumab).

This product consists of:

• Competitors described in a tabular format covering drug code/INN, target(s)/MoA, class of compound, territory of main competitor, indication(s) & R&D stage.
• Project History with link to source of information (press release, homepage, abstracts, presentations, annual reports etc).
• One-month online access to La Merie Publishing’s database for omalizumab (Xolair) biosimilar and biosuperior antibodies (prerequisite: access to internet).

This product is delivered on the very same day by e-mail containing competitor and project history reports in pdf format and database credentials. Reports are prepared on the same day.

Genentech and Tanox have been working together in collaboration with Novartis since 1996 to develop and commercialize Xolair^®, an anti-IgE monoclonal antibody approved by the FDA in 2003 as a treatment for patients with moderate-to-severe allergic asthma. By the acquisition, Genentech improved its financial results for Xolair by eliminating the royalty it paid to Tanox and by obtaining Novartis’ profit share and royalty payments to Tanox.

Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. XOLAIR is produced by a Chinese hamster ovary cell suspension culture. XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringes and in vials.

XOLAIR is an anti-IgE antibody indicated for moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older; chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older; and  chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older.

In pulmonary & respiratory diseases, omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcγRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcγRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation.

In urticaria, omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CSU symptoms is unknown.

Xolair’s substance patent has already expired and the formulation patent is set to expire in March 2024 in Europe and November 2025 in the U.S.

Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product.