A problem of perception

WHILE local generic drug producers battle with various patenting issues, they are not helped by most Malaysians’ perception that generic drugs are inferior because they are cheaper.

Contrary to the misconception, the Malaysian regulatory standard is high and on par with international standards, says Universiti Sains Malaysia School of Pharmaceutical Sciences professor Dr Yuen Kah Hay.

In fact, Malaysian drug companies are among the best generic producers in the South East Asian region, says Dr Yuen.

The Government imposes stringent standards on generic drugs, and bioequivalence studies are required before they can be registered and sold, he says.

(Bioequivalence studies are conducted using healthy volunteers to confirm that the absorbtion of the drug is similar to the patented product.)

A generic drug is deemed bioequivalent to the innovator product if it has similar rate and extent of systemic absorption of the drug, hence, should have similar efficacy and safety profiles, and they are inter-changeable (can replace the original product).

According to Dr Yuen, bioequiv- alence tests are costly – they cost more than RM150,000 – and will take three or more months to complete.

In fact, generic drugs can be better than the original drug products as the knowledge would have improved within the 20 years of the drug patent. The irony is, however, generic companies are not allowed to make a better drug product because it would then fail the bioequivalence test since it cannot be better than the innovator product according to the bioequivalence criteria, he says.

CCM Duopharma Biotech Berhad CEO Leonard Ariff Abdul Shatar says biosimilars (which involves genetic manipulation of cells of microorganisms in their production), could also be better than the originator product.

“Sometimes, the biosimilar product being produced is not an exact copy of the originator but it is even better. Unfortunately, that is not allowed,” he says.

The originator has cell lines that was developed 20 years ago to produce a particular end point product, and once they get the registration, the cell lines cannot be copied exactly by biosimilar companies.

But obviously, Leonard points out, after 20 years when patent expires, science would have improved tremendously and the cell lines that are used by the biosimilar producers may yield better results than the cell lines of 20 years ago.

“But, we have to ‘dumb it down’ in order to make it biosimilar,” he says.

Asked if biosimilar companies could patent the biobetter, he says “no”.

“It is like saying I have produced a sharper pencil and I can’t patent a sharper pencil.”

Leonard says generic drug producers never had to face this before because generic products involved small molecules and they only need to make an exact copy the originator drug but in the case of a biological product, it is impossible to make an exact copy.

He also points out that for some generics, prices could drop by as much as 70% but with biosimilars only between 30% to 50% because of the level of work that goes into registering it compared with a generic drug.

The requirements are more stringent than those for generic drugs, as they are required to do toxicology, preclinical studies and clinical trials from Phase 1 to 3, he says.

Asked why most local companies do not innovate and produce new drugs instead of producing generic drugs, Dr Yuen says it’s because they do not have the resources to develop a new molecule to put in the market as it costs at least US$500mil (RM2.067bil).

“Our universities do not have the funds to do that either,” he says.

Most local scientists also do not like to work in the pharmaceutical manufacturing industry as it is considered “laborious” and prefer to work in hospital settings and community pharmacies, he says.

“There have also been very few scientists trained in the pharmaceutical area, especially in industrial phamarcy with a PhD,” he says.

Dr Yuen urges the Government to give more grants and tax incentives to the local pharmaceutical industry to upgrade their plants and machineries as much savings can be made in the country’s healthcare expenditures.

It is also important to the health of the nation, he says, “Our local pharmaceutical industry can help make medicines more affordable to our people.”