Biobetters are emerging as a new frontier for the Korean pharmaceutical industry where most still focus on biosimilars led by Celltrion Inc. and Samsung Bioepis Co.

Biosimilars are biologic drugs that are similar to an already established reference biologic drug product, while biobetters possess some molecular modification of the original innovator drug with a more desirable pharmacokinetic/pharmacodynamic profile. But it usually takes a longer time and more money to develop a biobetter and is difficult to determine a therapeutic target.

Green Cross Co. is one of the most active companies in biobetter research in Korea. The drugmaker already commercialized one in Korea and recently launched a phase II study in the U.S.

Hunterase, a drug for rare disease Hunter Syndrome was recognized as a biobetter as molecular improvement was confirmed in a 2012 clinical study that compared it with reference drug Elaprase manufactured by a multinational company. The drug occupied more than half of the domestic market just two years after launching and generated sales of over 20 billion won ($17.5 million) from South America and North Africa last year.

Hanmi Pharm Co.’s drug-processing technology Lapscovery (Long-Acting Protein/Peptide Discovery) was designed to make a longer-acting drug than an original drug. This is an innovative approach because it would dramatically reduce regular shots for a diabetes patient, for example.

“The platform technology was applied to diabetes and obesity therapies which were out-licensed to global drugmakers and we will expand this technology into orphan drugs as well,” said Hanmi Pharm chief executive Lee Gwan-sun.

Ildong Pharm Co. recently announced a phase 2a study of ublituximab, a biobetter version of targeted cancer drug rituximab, was completed in the U.S. Rituximab is a blockbuster antibody product indicated for the treatment of lymphoma, leukemia and rheumatoid arthritis, generating 8.5 trillion won in worldwide sales in 2015. Rituximab selectively inhibits B-cells in lymphocytes involved in humoral immunity, while ublituximab is designed to boost this inhibition.

Hanall Biopharma Co. acquired by Daewoong Pharm Co. in 2015 has seven biobetter candidates in the pipeline including HL036, an investigational drug to treat dry eye. The new drug shows improved treatment outcome by adding a tear active ingredient to Restasis, a novel drug from U.S.-based Allergan Inc. A phase 1 study is due to be completed late this year.

By Kim Hye-soon

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