By Gatonye Gathura
The Kenya Medical Research Institute will start manufacturing cheaper cancer drugs called biosimilars.
“We have already procured a Sh 100 million fermenter, the main technology for making biosimilars and we could have a product in the market within five years,” says Dr James Kimotho, head of production at Kemri.
The move comes at a time dozens of locally developed high potential biomedical innovations are rotting in laboratories unable to break into the commercial market.
The new initiative if successful could dramatically reduce the cost of some crucial cancer medicine by up to 70 per cent while turning Kemri into possible money-making and job-creating venture.
Biosimilars are the equivalent of generic medicines, which are made through copying the original drug after patents have expired.
Many cancer drugs, vaccines and anti-diabetes are made from living organisms, rather than chemicals, hence called biologicals and whose copies are called biosimilars and not generics.
Last year the World Health Organization (WHO) approved the first biosimilar medicine – trastuzumab – used in the treatment of breast cancer and marketed as Herceptin.
On average, WHO indicates the original trastuzumab to cost about Sh2 million ($20 000) per treatment, while the biosimilar version is costing about Sh65, 000.
To put this into some perspective, the availability of generic ARVs from Asia about two decades ago, saw the cost of treating HIV drop from about Sh 1 million per patient annually to almost Sh5, 000.
This while helping put more than one million Kenyans on ARVs has made Asia home to some of the richest pharmaceutical manufacturers in the world.
“Biosimilars are the next big thing after generics and we want to be right at the head of the queue,” Dr Kimotho told the Standard in an interview last week.
This will be the second time for Kemri and third for Kenya to take a stab at the multibillion-dollar global pharmaceuticals market.
Around 2007 Kemri with technical assistance and an Sh760 million grant from Japan, opened a manufacturing unit and quickly started producing quality and affordable HIV and hepatitis diagnostic kits.
But in less than a year, Kemri was outmaneuvered out of the local and global diagnostics markets through technicalities placed by the WHO and big donors.
Related to this, between 2004 and 2006 pharmaceutical giants Roche and GlaxoSmithKline undertook to transfer technology for the manufacture of ARVs to several Kenyan companies including Cosmos Limited and Universal Corporation.
Two decades later, local companies are yet to benefits from lucrative HIV tenders dominated by the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR) despite investing in expensive WHO prequalification requirements.
Perviz Dhanani, CEO Universal Corporation says despite having the capacity to produce three million ARV tablets per week they hardly get any tenders from the big donors. He attributes this mainly to discriminative government policies against local manufacturers.
This means local entities have been effectively locked out of the domestic ARVs and HIV diagnostics market worth Sh96.5 billion in 2017.
“But we have not given up on commercialization of our research,” says Dr Cecilia Wanjala, the Commercial Manager at Kemri.
The institute’s Strategic Plan for 2018-2030, shows Kemri earning a paltry Sh25 million annually mainly from the sale of a hand sanitizer – Kem-Rub and an anti-tuberculosis disinfectant TB-Cide.
“We sell these mainly to the Kenya Medical Supplies Authority and the Mission for Essential Drugs and Supplies for use in hospitals, but since the advent of COVID-19 we have seen a spike in sales to the private sector,” said Dr Wanjala.
“Innovating may be the easier part compared to turning the same into money,” says Dr Michael Odotte who in 2004 developed a herbal antiretroviral for managing HIV.
Sixteen years on, even after the drug, Sunguprot, being registered with the Pharmacy and Poisons Board, patented, gone through clinical validation and incubated at the Kenya Industrial Research Development Institute (KIRDI), Odotte has yet to take the product to the market.
“We still need about Sh10 million to commercialize the product and a supportive policy, otherwise many brilliant local innovations remain white elephants,” Odotte told the Standard on Tuesday.
Our investigations revealed many high-potential (see examples below) local biomedical innovations that are underutilized, abandoned or stagnant, mainly due to lack of finances, commercialization skills or supporting policies.
For example, although the Health Act 2017 directed for the formation of a body to regulate the practice of alternative medicine in Kenya, this is yet to happen.
The products, the Act says will only be required to meet ‘minimum standards’ like happens with the Chinese traditional medicines now becoming popular in the country.
Kemri however, working on a directive from the Ministry of Health says it has just completed a draft policy on traditional medicine and medicinal plants, soon to be presented to the government.
Last year the Government put Sh8.2 billion in health research against a requirement of Sh13.6 billion but the Treasury says it is not getting value for the investment.
NB: Work on this article was supported by the African Academy of Sciences
Examples of underutilized high-potential local biomedical innovations
Mupal – University of Nairobi for the treatment of stomach ulcers
Zedupex – Kemri – anti-herpes
Sunguprot – KIRDI – HIV suppressant
Papina herbal salt – low sodium table salt – Kemri
Tungicide – anti-jiggers – Kemri
Firbroids treatment – Moi University
Kaposi Sarcoma (skin cancer) treatment – Kemri
Mondia Tonic – anti-depressant ICIPE
Naturub® – ICIPE – treating against common cold
The list contains only products that are registered and patented in Kenya