Eculizumab (Soliris) Biosimilars & Biosuperiors Pipeline Review

Eculizumab (Soliris) Biosimilars & Biosuperiors Pipeline Review

Reference Product: Soliris

Target: Complement C5

Product Category: Antibody

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

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 eculizumab (Soliris) 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.

Soliris was developed by Alexion Pharmaceuticals which was acquired by AstraZeneca.

Eculizumab, the active ingredient in Soliris, is a recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Eculizumab contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.

Soliris (eculizumab) injection is a sterile, clear, colorless, preservative-free 10 mg/mL solution for intravenous infusion and is supplied in 30-mL single-dose vials.

Eculizumab specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.

Soliris (eculizumab) is a complement inhibitor that works by inhibiting the C5 protein in the terminal part of the complement cascade. The terminal complement cascade, when activated in an uncontrolled manner, plays a role in severe rare and ultra-rare disorders.

Soliris, an intravenously administered therapy, is approved in the U.S., EU, Japan and other countries as a treatment for adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and for adults and children with atypical Hemolytic Uremic Syndrome (aHUS). Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).

In the U.S., Soliris is also approved for the treatment of generalized Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody-positive and for the treatment of NeuroMyelitis Optica Spectrum Disorder (NMOSD) in adult patients who are anti-AQP4 antibody-positive, in the EU as the first and only treatment of refractory gMG in adults who are anti-AchR antibody-positive and for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease, and in Japan for the treatment of patients with gMG who are anti-AChR antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).

Alexion owns an issued U.S. patent that covers the eculizumab composition of matter that expired in 2021, taking into account patent term extension. Alexion also owns other issued U.S. patents that cover the composition, use and formulation of eculizumab, that expire in 2027. Soliris was also protected in the U.S. by regulatory data exclusivity that expired in March 2019. Soliris also benefits from orphan drug exclusivity for treating gMG until 2024 (orphan drug exclusivity for Soliris for treating PNH and aHUS previously expired).

In Europe Alexion has supplementary protection certificates that extended rights associated with a composition of matter patent until 2020 in certain countries. Soliris was also protected in Europe by orphan drug exclusivity until 2019 for PNH, through late 2023 for aHUS and until 2027 for gMG. In Japan Alexion owns issued patents that cover the eculizumab composition of matter and expire in 2019 and 2027. SOLIRIS is also protected in Japan by orphan drug exclusivity until 2020 for PNH, until 2023 for aHUS and until 2027 for gMG.

In a patent settlement and license agreement, Alexion prevented the launch of Amgen’s Soliris biosimilar until March 01, 2025.

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.