South Korea’s biosimilar frontrunners Samsung Bioepis and Celltrion can anticipate scalable business growth in the next decade as references to their investigational biosimilars that include profitable cell and gene therapies will lose patented exclusivity over the next five years.

Patents on drugs that generated $78 billion for their producers last year will expire by 2026. They include macular degeneration drug Eylea, rheumatoid arthritis drug Actemra, breast cancer drugs Cadcyla and Perjeta, and allergic asthma and acute urticaria drug Xolair.

They face competition with biosimilars if their marketing exclusivity sunsets by 2026, according to a report from Biotech Policy Research Center.

This means more business opportunities for Korean biosimilar giants with the so-called 3rd-generation biosimilars, while their therapeutic areas will be enlarged to ophthalmology and dermatology beyond oncology.

Samsung Bioepis and Celltrion have so far released five and six biosimilar products, respectively.

Both are involved in biosimilar drugs of psoriasis drug Stelara, and osteoporosis drug Prolia currently in Phase 3 trials.

A market watcher said the industry closely watches third generation biosimilars composing of cell and gene therapies and immunotherapies, with a focus on MSD’s immunotherapy Keytruda as the copy market for the drug’s multiple indications could be explosive.

There are no approved biosimilars available in the therapeutic areas of eye health, dermatology, and gastroenterology. For biosimilar makers, the castle is left for the taking.

Among biosimilars in late-stage clinical trials, the copy treatment to aflibercept to treat macular degeneration are projected to grow fastest over the 2023-2030 period adding $12.4 billion in sales, the report said.

By Kim Si-gyun and Minu Kim

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