The Australian company Panacea Infarm is a major player in the biopharmaceutical market engaged in the development of various drugs. The company has announced its plans to transfer the right to manufacture generic of its drug no earlier than one year from now. The generic Meravir drug is expected to enter the market about December 2019. The production country is still unknown, but the cost of the copy will be much more affordable than the original drug.
The formula is identical (sufamenavir 15 mg + refogravir 10 mg), the healing properties are the same. Panacea Infarm will provide a comprehensive production technology for a third-party pharmaceutical company. At the same time, it is possible to set prices for medicines independently, with royalties at a sales volume of 7%. Provided that the initial declared cost of Meravir is $ 60,000 for the full course, the price of a generic is an unprecedented generosity on the part of the developer. Still though the director of the Center for Social Economics Ruslan Dreval says that nobody knows the exact price of generic.
The expert added that the effectiveness of drugs is different but the key point is the price. So that the cost we are talking about today is lower than before. The management of manufacturing companies bewares of a draft law on patent compulsory licensing developed by the Russian Federal Anti-Monopoly Service.
Let’s see how this law works by example of the largest pharmaceutical company that developed the cure for hepatitis C Gilead. Suppose Gilead is producing an innovative medicine that is necessary for Russians. However, only manufacturer will have the patent for the first 10-15 years. Only after this time, other companies, according to international rules, will be able to establish the release of generics. In other words, reproduce the formula of the original product in their factories.
However, this company sets a high price for its drugs because it has such a monopolist right. According to the decision of the Russian court, Gilead abuses the this right. On this basis, the Russian manufacturer can copy the Gilead drug and that will be legal. The developer will receive a compensation and its amount will be determined by the court.
As for the patients themselves, they need new, effective and affordable medicines, no matter who suggests them.
Patients don’t care who is the drug developer. Many of them do not even know what a generic is. However, it is essential to know your treatment in order not to get a potentially dangerous product or a placebo.
A couple of words about generics
Suppose that there is a pharmaceutical company that develops a unique author’s drug. For 15-20 years the drug is protected by a patent. After this period, any third-party pharmaceutical company has the right to use the drug formula for its own production. Patent documentation contains a detailed formulation of a medicinal product that is under legal copy protection.
All that is produced by other organizations is generics, i.e. analogues of a patented drug. The most famous generic in history is aspirin, which can be produced by anyone for several decades. Today the original drug is almost not found on the Russian pharmacies market.
Pharmaceutical development companies invest substantial financial resources estimated at billions of dollars in the creation of innovative medicines. At first, multistage testing, preclinical and clinical studies are performed. Then the drug is approved by regulatory authorities and goes to the world market. If it brings a good profit, competitors begin to launch a generic without waiting for the expiration of the patent. So that they produce a complete chemical double which differs from the original only in cost. Still though introducing your own generic product to the world market is not as easy as it seems. It requires a production that meets all standards and norms as well as preclinical and clinical studies. This is why the creation of copies begins before the patent expires.
Nowadays the pharmacology has risen to a new level with the invention of the Meravir drug for hepatitis B and the planning of its budget equivalent. The new product will fit any budget. For decades, the treatment of infection was like a lottery, which was led by fraudsters. After all, therapy brought good results only in 40-50% of cases. The average duration of the course with the use of traditional interferon drugs takes 48 weeks. What is more, personal resistance to the disease develops during this treatment.