Global Biosimilar Development Updates

Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have already reported:

Today, December 3, 2018, Celltrion announced that the European Medicines Agency (EMA) has accepted Celltrion’s Extension Marketing Authorisation Application for “Remsima SC,” a subcutaneous version of its Remsima® (infliximab) biosimilar product.  Celltrion states that an opinion on the application from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in the second half of 2019.

Also today, Momenta announced that it has decided to further delay its submission of an aBLA for M923, its proposed biosimilar of Humira® (adalimumab), in view of its recent license agreement with AbbVie that authorizes Momenta to launch its biosimilar (if approved) in the United States as early as November 20, 2023.  According to Momenta, delaying the filing of the aBLA “may reduce program costs in 2019 without delaying potential US market entry for M923.”

On November 28, Daiichi Sankyo announced that it had launched a biosimilar of Herceptin® (trastuzumab) in Japan, following its regulatory approval this past September.  According to the press release, the product, Daiichi Sankyo’s first biosimilar, was developed by Amgen, which will remain responsible for manufacturing the product while Daiichi Sankyo will be in charge of distribution and commercialization in Japan.

On November 20, Formycon provided updates on its biosimilar development programs.  First, with respect to FYB201, its biosimilar candidate referencing Lucentis® (ranibizumab), Formycon announced the availability of clinical data from a phase III trial in patients with neovascular age-related macular degeneration (nAMD), and that Formycon’s partner Bioeq IP AG, which holds the exclusive global marketing rights for this product, has filed a request for a Type IV pre-submission meeting with the U.S. FDA, which will be held in December 2018.  According to the press release, plans are in place to submit an aBLA to the FDA during the first half of 2019, and that a pre-submission meeting with the EMA is planned for the first quarter 2019.  Formycon also reported that scientific advice briefing books were submitted to the FDA and EMA for upcoming meetings regarding FYB202, a proposed biosimilar of Stelara® (ustekinumab), and were being prepared for FYB203, a proposed biosimilar of Eylea® (aflibercept).  Formycon further stated that “[t]he initiation of the clinical testing of FYB202 is planned for mid-2019.”

On November 19, Alvotech and Fuji Pharma announced that they had entered into an exclusive partnership through which Fuji Pharma will commercialize Alvotech’s biosimilar portfolio in Japan.  The joint press release indicates that “Alvotech will be responsible for development and supply of multiple high value biosimilar assets from its current product pipeline, while Fuji Pharma will be responsible for registration and commercialization of these assets in Japan.”  The press release does not provide specifics about Alvotech’s biosimilar portfolio, but states that it “includes high value products used in advanced therapies of oncology, ophthalmology and autoimmune disease that generated over $32 billion in global sales in 2017 (Evaluate).”  According to ClinicalTrials.gov, “Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient.”  This was the second biosimilar partnership that Alvotech announced in recent months.  In September, Alvotech reported that it was entering into a joint venture with Changchun High & New Technology Industries Group that “will enable Alvotech to develop, manufacture and commercialize its biosimilar portfolio in China.”

On November 13, Innovent Biologics announced that China’s National Medical Products Administration (NMPA) had accepted IBI303, Innovent’s proposed biosimilar of Humira® (adalimumab).  The press release states that the application was based on Phase 3 comparative efficacy and safety studies that were conducted in patients with ankylosing spondylitis, as well as comparative pharmacokinetic and immunogenicity studies.

On November 8, the Korea Biomedical Review reported that GC Pharma had launched Biocon’s Glargia®, a biosimilar of Lantus® (insulin glargine), in South Korea.  The report indicates that Handok Pharmaceutical “will be responsible for domestic marketing and sales activities for Glargia” under a promotional and wholesale agreement that GC and Handok executed this past January.  As we previously reported, GC received Korean regulatory approval earlier this year.

Download PDF