Domestic pharmaceutical companies are expecting to grow their U.S. market share in 2018.
Many domestic pharmaceutical and biotechnology companies, including GC pharma, formerly known as Green Cross, Gtree BNT, and Daewoong Pharmaceuticals, are pushing for U.S. Food and Drug Administration’s approval for their newly developed medicines.
GC Pharma is awaiting FDA approval for its IV-Globulin SN (IVIG-SN). The drug treats various diseases, including congenital immunodeficiency disease and immune thrombocytopenia. The medicine has already proven marketability as it recently signed a 47 billion won ($42.9 million) export contract to supply IVIG-SN to Brazil.
Stock market analysts predict Green Cross will be able to win FDA approval in the first half of this year.
The company has taken steps to compete in the U.S. market by opening Korea’s first biopharmaceutical plant in North America. The factory, located in Montreal, Canada, is expected to produce a million liters of plasma derivatives, such as IV immunoglobulin ((IVIG) and albumin, annually.
Gtree BNT aims to enter the U.S. market by marketing RGN-259, a TB4-based sterile and preservative-free eye drop, which treats dry eye syndrome and neurotrophic keratitis. The company plans to apply for FDA approval this year as it completed phase 3 clinical trials in October.
Daewoong Pharmaceutical is preparing to enter the market with Nabota, a botulinum toxin type A. The FDA finished inspecting the company’s factory in Hwaseong, Gyeonggi Province, in November. If the FDA gives a cGMP certification to the plant, the company plans to begin sales of its product in the second quarter of this year. The company also plans to apply for FDA approval of Ursa, a hepatic protector.
Other companies such as SK Biopharmaceuticals, Viromed, Hanmi Pharmaceutical and LSK Biopharma plan to apply for FDA approval by the end of this year. The companies are conducting phase 3 clinical trials for their products.
Domestic biosimilar giants, Samsung Bioepis and Celltrion, also plan to increase U.S. market share.
Celltrion’s Remsima (Original: Remicade), a therapy to treat autoimmune diseases, is steadily increasing its share in the American market.
Distributed by Pfizer as Inflectra in the U.S., the drug posted $34 million in revenue in the third quarter of last year, up 47.8 percent from $23 million from the previous quarter. The company also expects to receive approval for Herzuma (ingredient: trastuzumab), an anti-cancer antibody biosimilar used for the treatment of breast and stomach cancer, in the second half of this year.
Samsung Bioepis has also received approval for its biosimilar version of Remicade, Renflexis. Merck Sharp & Dohme (MSD), who is in charge of Renflexis sales in the U.S. and Canada, will compete in the autoimmune disease market with Remicade and Inflectra.
The company also aims to receive FDA approval for Ontruzant, which treats early breast cancer, metastatic breast cancer, and metastatic gastric cancer. The company announced that the FDA has accepted its biologics license application (BLA), and started reviewing the drug on Dec. 20.