A number of South Korean biopharmaceutical companies are expecting a boost in their product exports to North America as they draw closer to securing regulatory approval to commercialize their new drugs in the US market this year.

Nearest to this goal is GC Pharma, a Korean biopharma company formerly known as Green Cross. The company expects the US Food and Drug Administration to approve its immunodeficiency treatment IVIG-SN, short for human normal immunoglobulin G for intravenous administration, in September.

Last year, the US drug regulator rejected Green Cross’ biologics license application for IVIG-SN, asking the company to provide supplementary information on the drug’s manufacturing procedures. The Korean drugmaker submitted the data in March this year in hopes of a conclusive approval. 

“We submitted the required additional data for IVIG-SN to the US FDA in March this year. If all goes as planned, we expect the drug to secure conclusive approval in September,” a GC Pharma spokesperson said.

With IVIG-SN, the company plans to target the US immunodeficiency disease treatment market, which makes up around half of the global market for this drug segment, estimated at around $10 billion.

Exclusively developed by Green Cross, IVIG-SN is a plasma-derived protein drug that treats primary immunodeficiency disorders that weaken or rid the immune system’s ability to fight infectious diseases.

The drug, already being sold in more than 30 countries in Asia, South America and the Middle East, is one of the Korean drugmaker’s top-selling plasma-based biologic treatments.

If approved in the US, it would allow Green Cross to significantly expand its presence in North America as well as the global market for IVIG-SN and injectable plasma-derivative drugs.

Another firm nearing US entry is SK Biopharmaceuticals, the new drug development unit of Korea’s telecom-to-energy conglomerate SK Group. The unit is awaiting the US FDA’s marketing approval for an investigational narcolepsy drug, solriamfetol.

In March this year, SK Biopharm and its partner Jazz Pharmaceuticals said that solriamfetol had been accepted for standard review by the US drug regulator. Jazz Pharmaceuticals expects the US FDA to make a decision on the approval by Dec. 20, 2018, in line with the Prescription Drug User Fee Act goal date.

Solriamfetol is an investigational drug designed to treat excessive sleepiness in adult patients with narcolepsy, a debilitating neurological disorder characterized by excessive sleepiness, or obstructive sleep apnea, characterized by pauses in breathing during sleep.

The drug compound was originally discovered by SK Biopharmaceuticals, but licensed out to Aerial Biopharma in 2011. Later, Aerial Biopharma sold its rights to solriamfetol to Jazz Pharmaceuticals in 2014.

Now, Jazz Pharmaceuticals holds the worldwide development, manufacturing and commercialization rights for the narcolepsy drug, with the exception of 12 markets in Asia, where SK Biopharm retains its rights.

If solriamfetol is commercialized in the US, SK Biopharmaceuticals is expected to reap double-digit royalties from the drug’s sales in the US, the company said.

Meanwhile, Daewoong Pharmaceutical is on track to obtaining the US regulator’s approval of its Type A botulinum toxin drug Nabota, set to become the first BTX alternative to hit the US market. However, the approval will likely come next year.

Daewoong, along with its US partner Evolus, submitted a biologics license application for Nabota to the US FDA in May 2017, with aims to commercialize the drug in the US by the end of 2018.

But in May, the US FDA rejected its application by issuing a complete response letter, citing deficiencies related to the chemistry, manufacturing and controls processes, and in turn delayed the drug’s entry to the US.

Despite the dampened outlook, the companies have cited plans to soon refile an application with supplementary documents, with the aim of obtaining the US regulator’s final marketing approval by next year.

Other US-bound drugs from Korean companies include Rolontis (eflapegrastim), a treatment for the management of chemotherapy-induced neutropenia, which was developed by Hanmi Pharmaceutical and in-licensed by US-based Spectrum Pharmaceuticals in 2012.

Spectrum Pharmaceuticals has announced that it will file a biologics licensing application for Rolontis to the US FDA within the fourth quarter of this year.

Celltrion, a Korean drugmaker specializing in the development of biosimilars, is also awaiting US marketing approval for two new biosimilar drugs -- Truxima and Herzuma. Biosimilars are lower-cost copies of biologic drugs whose patents have expired.

Truxima is a biosimilar referencing rheumatoid arthritis drug Rituxan (rituximab), while Herzuma references the blockbuster breast cancer treatment Herceptin (trastuzumab).

Celltrion -- which resubmitted the drugs for a second review after their initial turndown due to manufacturing-related issues in May and June -- said it expects both drugs to obtain US marketing approval by the year’s end.

By Sohn Ji-young (jys@heraldcorp.com)