Consistency evaluation enters harvest period, 882 generic drug reviews

Pharmaceutical Network Industry Dynamic" Consistency evaluation is the quality and efficacy consistency evaluation of generic drugs, including both quality and efficacy, in the original materials of drugs, production process, quality testing and efficacy, there are strict standardsAfter the election, the drug regulatory department will strengthen supervision and inspection and product sampling, strengthen the full-cycle quality supervision, ensure the quality and efficacy of drugs, so that the masses can use the medicine at easeAt present, with the promotion of consistency evaluation, some pharmaceutical companies have ushered in the harvest period of consistency evaluationFor example, Fosun Pharma recently announced that the subsidiary Shanghai Zhaoxuan received the "Drug Supplement Application Approval" issued by the State Drug Administration on the Picaluamine tablets, the drug passed the consistency evaluation of generic drugs; Production was approved, as if through the consistency evaluation, for the first drug in the country over-evaluation; recently, yuyuan medicine evening announcement, subsidiary OfO Medical Health Haslin recently received the State Drug Administration approved the issuance of "Ibasin tablets" of the "drug supplementary application approval", the drug through the quality of generic drugs and efficacy consistency evaluation... according to theaccording to incomplete statistics in the industry, up to now, 882 generic products have passed or as if through the consistency evaluation, 167 product regulations have been evaluated more than two, 88 product regulations have been evaluated more than three, over three or more 88 product rules, the number of manufacturers rated for the perisulphate (5mg specification) as high as 30, the number of metformin sulphate tablets (0.25g specifications) followed closely, the number of manufacturers rated for 22, in addition, metformin hydrochloride release slowly Tablets (0.5g specification), Amoxicillin capsules (0.25g specification), acetaminophen tablets (0.5g specification), montacon (3g specifications), Fumaictinofe IIestae (300mg specification) and other products rated more than 10 manufacturersin accordance with the relevant national policies, for the evaluation of varieties, in the medical insurance payment to give appropriate support, medical institutions should give priority to procurement and clinical priorityIn addition, centralized procurement is based on a criterion for inclusion through consistency evaluationAccording to the current situation of production of quantity procurement, the varieties included in the collection is basically a more generic drug evaluation enterprises, the industry expects the third batch of band quantity procurement will follow three and more competitive models, that is, "2 and above over-rated s 1 original research", the number of over-rated entrepreneurs in 2 and above (excluding the original research) varieties may be included in the third batch of band procurement collectionincluding the high probability of the varieties include metformin oral reprehension / reprieve agent form, katopritablets, tegrelo tablets, ammonia bromine oral reprieve form, apixaban tablets, etc, involving listed companies including Hengrui Pharmaceuticals, Fosun Pharma, Stone Pharmaceutical Group and China Biopharmaceuticalswith the promotion of band procurement policy, the market pattern of related varieties may be affectedFor example, Stone Pharmaceutical Group, China Biopharma has now completed a consistency evaluation of the big varieties of the Forgreo tablets of more than 500 million yuan, but the original pharmaceutical company AstraZeneca occupies the main market share, the original research sales reached 495 million yuanThe industry believes that if the Grelo film successfully included in the third batch of national collection, or break the situation of the monopoly market, but from the previous rounds, AstraZeneca actively participate in the operation of the volume procurement, its or reduce the amount of protection to maintain their market positionin general, with the promotion of consistency evaluation, band procurement and other policies, if the third batch of national collection continues the second batch of bidding ideas, the price competition of related varieties is inevitable, the competition will be more intense.