FDA issues nomenclature rules for biological analogues

Source: the naming rules proposed by the FDA on September 1, 2015 are intended to solve two main problems: 1 Help prevent the substitution of biological drugs not authorized by the FDA due to negligence (which may lead to medication errors); 2 Accurately track the use of biopharmaceuticals in all locations, such as outpatient department, hospital and pharmacy, so as to monitor the safety of all biopharmaceuticals after the products are put on the market After many lobbying and public debates in the industry, FDA has finally proposed a biological similar drug naming system in recent days This naming system consists of two parts, the common name and the unique trade name The naming rules will make it easy for some bio similar drugs to replace the original brand drugs, while others are relatively difficult Replaceability qualification needs to be evaluated according to FDA's plan, whether it is brand drug or biological similar drug, the name has a name of "core drug ingredient" In addition, each product will have a four letter suffix Different product suffixes are different For example, for the same product, there are different suffixes for biosimilars, MSD and Lilly However, according to the FDA's recommendation, the suffix cannot be a derivative of the manufacturer's name Drugs with different suffixes will not automatically replace each other This seems to be a "victory" for branded drug manufacturers, which have been trying to limit the rapid and easy substitution of biologically similar drugs for branded drugs However, manufacturers of biologicals need not worry too much The FDA is seeking advice on different ways to assess the substitutability of biosimilar drugs For biologically similar drugs that can be substituted for each other, it may be possible to use the same suffix as the brand drug Just like a large number of chemical generic drugs use the same generic name as brand drugs For example, Novartis' Diovan, commonly known as valsartan Such regulations can make it easy for these biological analogues to replace the expensive original products This approach makes FDA not simply limit the substitution of biological analogues with specific reference substances, but theoretically allow FDA to choose among biological analogues Therefore, FDA can give a specific bio similar drug and brand drug substitutability qualification, but other bio similar drugs of the same brand drug may not have this qualification In recent years, with the FDA opening the door to the approval of biosimilars, the nomenclature of biosimilars has been a hot topic The developers of bio similar drugs naturally hope that their drugs can easily replace brand drugs, the same is true for the payers, because they are trying to reduce costs, and if relatively cheap bio similar drugs can easily replace the original research drugs, it means lower costs However, brand drug manufacturers want to maintain sales, so they will not want to be replaced quickly and easily In addition, medication errors and safety concerns are also the most concerned issues of bio similar drugs The FDA's nomenclature also hopes to address these two issues On August 27, the FDA wrote on its blog that it should prevent products that have not been granted substitutability from being inadvertently replaced, and allow the FDA and pharmaceutical companies to track every biological similar drug to find any possible safety problems Next, the industry's feedback and suggestions on the nomenclature will emerge, expecting a fierce debate between manufacturers and their competitors with sales of more than 10 billion products.