Is Celltrion’s biosimilar Remsima safe and effective?

It may be a stupid question, given that the drug has won approvals in the United States and Europe to become a globally recognized rheumatoid arthritis treatment.

Still, I was curious: How might doctors abroad -- i.e. advanced countries, including the U.S. -- think of the Korean biosimilar? What are the responses in “real world,” meaning the clinical fields different from “designed environment” like clinical trials?

Regulators approve medical products on the premise that the drugs ensure efficacy and safety through large-scale clinical trials.

Doctors in “real world,” however, do not prescribe drugs based only on efficacy and safety proven by clinical tests. Rather, factors not related to clinical trials, such as insurance coverage and patients’ financial conditions, exert greater influence on the prescription of medicine. Sometimes, medical professionals find side-effects, which were regarded as insignificant or not exposed at all in clinical experiments, in the real world.

It is true biosimilars, like generics, follow the paths paved by original drugs. However, you should not equally evaluate the characteristics of “bio” that use antibody with synthetic chemical medicines. That also explains why generic drugs of biomedicines have the label of “similar,” not generic.

It is against this backdrop that question marks had hung over the efficacy and safety of Remsima, entitled the world’s first biosimilar by the Korean approval system, until it won approvals in Europe and the United States. However, Remsima got over the European and U.S. hurdles to prove the concerns of many people, this reporter included, groundless and has positioned itself as the globally recognized biosimilar true to its name.

The only thing left was doctors’ assessment in the real world. I was particularly curious about doctors’ opinions in North America, the world’s largest medical supply market.

Then I happened to interview Algis Jovaisas, a Canadian scholar and professor of rheumatology at the University of Ottawa, who visited Korea at the invitation of Pfizer Korea. I asked Professor Javaisas whether he has used Korean biosimilars, including Remsima, and what his personal opinions were about them.

His comments couldn’t be more favorable.

“There are no differences at all between biosimilars and original biological products in standards they should meet as medicines. No are there any differences in the manufacturing process, and so regulators regard biosimilars as ‘new biological agents,’ and not as ‘generics,’” he said. “I toured the plants of Celltrion and other companies to watch their manufacturing process of biosimilars, and found no differences in the production environment with developed countries.”

Professor Jovaisas said he prescribes biosimilar on 25-30 patients and found them effective in most cases. “I prescribe biosimilars, especially those produced by authenticated companies, with little concerns,” he added.

Korean doctors are prescribing fewer biosimilars than expected. As there are little price differences between original drugs and biosimilars, doctors don’t feel much cost-cutting effects, the biggest advantage of biosimilars.

It is understandable given we can’t tell patients getting treatments with original medicine to shift to biosimilars “showing patriotism.” All this notwithstanding, Celltrion, the developer of Remsima, is unlikely to feel sorry very much. And I don’t feel much needs to say why.

pkt77@docdocdoc.co.kr

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