GCC could be biotech hub

Essam Hammad / 16 February 2014

The uae government’s recent retreat to brainstorm on the future of healthcare in the country coincided with an important and highly-relevant healthcare event held in Dubai by Julphar, the UAE pharmaceutical company, to discuss the creation of a world-class biotechnology and biosimilars industry in the Mena.

As technology based on biology and other life sciences, biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve people’s lives. In the pharmaceutical field, modern biotechnology provides breakthrough products and technologies to combat serious and rare diseases. A biosimilar is a biological product that gets approved based on demonstrating it is similar to an already approved biological product (reference product). Biopharmaceuticals include vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials.

The Julphar Forum was an ideal platform for participants from different markets to share their own experiences in establishing biotechnology and biosimilars in their relevant markets and debate the feasibility of a successful biotechnology and biosimilars industry in the region.

It was revealed during the forum that the biotech industry is experiencing small ($1-$10 billion) licences, more than big ($30-$60 billion) orders, and that it is expected to grow to $205-$235 billion in 2017. Also, emerging markets are growing rapidly; China is expected to be No. 2 in 2017, immediately after the US, whereas the Middle East is currently not “on the map” as a possible education and production location.

As early as 2005, the US biotechnology industry invested $12.8 billion in research and development and Europe’s biotech sector invested only $2.7 billion. Likewise, China’s R&D “intensity” — the ratio of an organisation’s expenditures on R&D to its sales — grew 17 times more than the European Union’s between 1999 and 2003. At that time, you could barely hear about biotechnology in the Arab World.

It is believed that biotechnology can potentially transform the healthcare sector. The quality and improved accessibility that come with biotechnology are now established facts that no one currently questions. A regional biotech and biosimilars industry will therefore help take the quality in the regional healthcare sector to the next level, producing new efficient remedies and improving accessibility. Also, a local biotechnology and biosimilar industry might very well help in reducing the increasing financial and healthcare burden on governments and people in the region.

There are, however, some obstacles that should be surmounted before the way can be paved for biotechnology in the Mena region.

Regulations: Countries in the Mena region do not have a common regulatory framework to approve medicines; every product has to be approved by each individual country, which means one product needs 22 approvals. Undoubtedly, this represents a huge obstacle to innovation in the region and drive investors away from the business. For this obstacle to be removed, it is clear that governments in the region need to move quickly towards setting a unified regulatory framework that ensures quality processes and end products without curbing innovation or disappointing investors and manufacturers. Europe has already approved the first monoclonal antibody biosimilar, and the US is finalising its biologics guidelines. The Mena region, however, hasn’t yet initiated structured dialogue on how to address the regulations impediment.

Innovation: As a highly-complicated research field, biotechnology and biosimilars depend heavily on science, technology and availability of highly-qualified talent. Obviously, this tripartite platform isn’t yet mature in the Mena region. It is worth mentioning, however, that Julphar, depending on its own capabilities, has already made inroads into the biosimilar field to produce insulin raw material locally, which has made of the UAE one of the few countries in the world producing insulin and exporting it to other markets. This was a breakthrough made by Julphar and it is time now for all stakeholders to build on it and set the way for a mature biosimilars industry in the region.

Clearly, government agencies, higher education institutions and healthcare providers all need collaborate to find the right formula to build the desperately required innovation platform. We are not reinventing any wheels here and we need to learn from the experiences of markets developed in biotechnology and biosimilars. Alternatively, the innovation gap can be bridged by collaboration programmes with global leaders or by mergers and acquisitions. The Mena region, though small, is a promising emerging market for biotech giants and we need to seize this strength to lay the know-how grounds for biotechnology in the region.

Investments: No doubt, biotechnology and biosimilars require huge investments. For instance, the advanced diabetes biosimilar plant that Julphar established in 2012 cost $150 million. Also, it is estimated that a biosimilar product would cost from $75 million to $250 million, which means that any company needs to invest over $1 billion to produce only 10 products. Added to this, a biotech product needs six to seven years to reach the stage of marketing and ROI. This fact decreases the allure of biotechnology to private and institutional investors. Hence, it is evident that governments and healthcare providers have a role to play to secure the necessary funds for R&D and incentivise investors.

Considering the benefits of biotechnology to economies and healthcare sectors in Mena, governments are expected to subsidise biotech companies and support them so as not to feel left alone exposed to risks. If this doesn’t happen, the trend of shying away from biotechnology will most probably persist. South Korea provides yet another instance of how government support for biotechnology pays off. As was revealed by the Samsung representative who participated in the forum, the South Korean government subsidised the local biotechnology industry in early stages, which has led to establish local innovation in the biotech and biosimilars sector. Early stage support by governments in the region is imperative.

A world-class biotechnology industry is of great importance for the future of quality healthcare service in the Mena region. Governments and healthcare providers should support the emerging industry by agreeing on a common regulatory framework, subsidising early stages of the business and putting in place the innovation platform indispensable for the long term success of biotechnology. Having the funds necessary for biotechnology and being more developed in terms of technology adoption, GCC countries seem to be better placed to lead the Mena efforts in building a world class biotechnology industry in Mena.

The writer is director of Biotechnology at Ras Al Khaimah-based Gulf Pharmaceutical Industries, known as Julphar. Views expressed are his own and do not reflect the newspaper’s policy.