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Drugs, medicines in the form of biosimilars are the future: Experts
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DUBAI: “Biosimilars are the medicines and medical products of the future. In fact, ‘one in five drugs in the next two years’ have been projected to be biosimilars.”

These were shared by senior management level officials of the German pharmaceutical company, Boehringer Ingelheim (BI), with newsmen from the UAE and Lebanon at the “Roundtable Media Discussions on Biosimilars” as part of the recently-held Bilanzpresskonferenz 2015 (Global Annual Press Conference 2015) in Ingelheim, Germany.

Meanwhile, from Ras Al Khaimah, UAE, Julphar Gulf Pharmaceutical Industries on Monday announced that it had successfully concluded the phase one clinical trial of its biosimilar human insulin.

The study was done at Profil Institute for Clinical Research in Germany.

Julphar chief executive officer Dr Ayman Sahli said, “The approval of this study by the German BfArM, and its successful conclusion, is an important step for our company’s biosimilars programme.

“This makes our company the first entity in the Middle East to have clinical trial filing accepted under the EMA (European Medicines Agency) biosimilar guidelines,” he added.

BI Corporate Board Division-Biopharmaceuticals & Operations member Dr Wolfgang Baiker told The Gulf Today that biosimilars “have identical genetic information as those of the originals or patented medicines and medical products but have a different overall make-up.”

It has been a trend among the various drug firms in the world to manufacture biosimilars since patented medicines and medical products cannot be copied or replicated by any pharmaceutical company in the number of years that these are patented which typically runs for 20 years.

Biosimilars are manufactured with the goal of maintaining and sustaining public health and safety.

Julphar’s Sahli said, “Biosimilars can play an important role in broadening access to high-quality biologics and optimistic that the savings generated through the use of biosimilars can be used to fund other unmet medical needs.”

BI Corporate Board Division Pharma-Marketing & Sales managing director Allan Hillgrove who forecast that there would be one biosimilar in five medicines or medical products in the next two years claimed the production “does not happen quickly.”

Baiker claimed biosimilars are developed in eight years time for potency.

He added that one of the challenges is to demonstrate “the efficacy of these biosimilars” to the international regulatory bodies.

Currently, the company has three biosimilars in late stage production phase and two in pre-clinical stages.

It was on Jan 17 to 19, 2013 that the UAE Ministry of Health (MoH) organised the “1st Regional Conference on Biopharmaceuticals and Biosimilars” participated in by 10 countries from the Middle East and North Africa as well as nearby regions.

From the event, MoH-Public Health Sector and Licensing Policy assistant undersecretary Dr Amin Hussein Al Amiri pointed out that the UAE “is committed to developing and implementing clear and stringent regulation for all pharmaceutical products, including the highly complex category of biopharmaceuticals and biosimilars.”

University of Barcelona-Pharmacology, Therapeutics & Toxicology Department professor Dr. Fernando de Mora said, “The manufacturing process of a biotech medicine is tightly linked to the final structure, so the smallest change in this process can alter the final products and potentially impact the safety and efficacy of the medicine.”

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