The World Health Organisation has announced a plan to approve generic versions of two expensive bio-therapeutic anti-cancer molecules in an effort to make them available to low and middle-income countries.
It said it would invite manufacturers to submit applications for pre-qualification of biologically similar versions of rituximab, used to treat chronic lymphocytic leukaemia and non-Hodgkin's lymphoma, and trastuzumab, used to treat breast cancer.
The pre-qualification process is a mechanism to certify that the generic versions of these bio-therapeutic molecules are pharmacologically similar to the more expensive products from innovator companies.
"Innovator bio-therapeutic products are often too expensive for many countries, so bio-similars are a good opportunity to expand access and support countries to regulate and use these medicines," Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, said in a media release.
|If the WHO finds that the bio-similars for pre-qualification are comparable to the originator products in terms of quality, safety and efficacy, it will list the medicines, which will become eligible for procurement by UN agencies. Many low and middle-income countries too rely on pre-qualification before procuring medicines.|
Cancer specialists in India say that generic versions of both rituximab and trastuzumab are already available in the country, and their entry into the market had forced a reduction in prices of the originator products to comparable levels.
"When domestic generic companies began making these medicines, the prices converged to lower levels," said Raju Titus Chacko, professor of medical oncology at the Christian Medical College, Vellore. "The entry of the generics and price control by the government have both helped reduce prices."
The WHO move for pre-qualification for the two anti-cancer bio-similars follows a two-day meeting in Geneva between its senior officials, national regulators, pharmaceutical industry representatives, patients' groups and health policy makers.
In women with non-metastatic breast cancer that over-expresses a molecular receptor called HER2, the addition of trastuzumab to chemotherapy reduces mortality by over 30 per cent. Multiple clinical studies have suggested that even in metastatic cancer, the addition of trastuzumab is associated with increased overall survivals.
The National Pharmaceutical Pricing Authority had, ahead of a brainstorming session two years ago on the pricing of oncology medicines, underscored the differences between the costs of originator bio-therapeutics and their generic versions.
According to figures from last November, the average cost of trastuzumab was about Rs 50,000 per vial and the cost of treatment for an average-sized adult was estimated to be about Rs 800,000. Generic versions of trastuzumab were available at Rs 45,000 per vial, and the cost of full treatment was estimated at Rs 675,000.
Similarly, the inclusion of the innovator brand of rituximab in chemotherapy would cost about Rs 228,000 for the full course of treatment, while generic brands of the drug would cost Rs 132,000 for treatment.
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