Samsung Bioepis recently announced in a press release that the U.S. FDA has accepted the company’s Biologics License Application for its biosimilar drug candidate SB2, which references Remicade (infliximab). The drug is indicated for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, rheumatoid arthritis, ulcerative colitis, and Crohn’s disease.
“We will continue our relentless drive for innovation and further advance one of the industry’s largest biosimilar pipelines, so that more patients can have access to affordable medicines without compromising the quality of treatment,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.
SB2 is the company’s first biosimilar candidate, which will be marketed and distributed in the U.S. by Merck according to a commercialization contract signed in 2013.
“At Samsung Bioepis, we are dedicated to bringing affordable, high-quality biologic medicines to patients across the United States. Already in other countries, our biosimilars have started to play an important role in increasing patient access to high-quality treatment options, while driving down healthcare expenditures. We hope to do the same in the U.S.,” Ko said.
The submission was based on clinical trials that evaluated the biosimilarity of SB2 in comparison to Remicade. The 54-week Phase 3 clinical trial demonstrated that the safety of SB2 is comparable and the efficacy of SB2 is equivalent to Remicade. The randomized clinical study included 584 participants from 73 clinics in 11 countries who suffered from moderate to severe rheumatoid arthritis, even after receiving methotrexate treatment.
The company has 13 biosimilar drug candidates in its pipepline, including these candidates from therapeutic areas such as oncology, immunology, and diabetes:
- SB4 biosimilar drug candidate (reference: Enbrel)
- SB2 (reference: Remicade)
- SB5 (reference: Humira)
- SB9 (MK-1293) (reference: Lantus)
- SB3 (reference: Herceptin)
- SB8 (reference: Avastin)
The company exclusively develops and manufactures all the oncology and immunology biosimilar drug candidates. It is responsible for global clinical trials and regulatory registration in all markets around the world for these biosimilar drug candidates. Upon approval, Samsung Bioepis biosimilar drugs are marketed and distributed by its commercialization partners, Merck and Biogen.