The $6.8 billion "cash cow" is facing generic Roche and Amgen

Source: biological exploration 2017-2-27 Biosimilars benefit patients more because they are cheaper, but it means a huge loss of profits for patent owners Avastin, a cash cow anti-tumor drug with annual sales revenue of 6.8 billion Swiss francs (about 6.8 billion US dollars), is sued by Roche, a Swiss pharmaceutical giant, against Amgen Roche's Genentech recently appealed against Amgen, saying that the other side failed to provide enough information for Genentech's experts to assess whether Amgen's biosimilars infringed on Avastin, the company's sfr6.8 billion cash cow Genentech said the consequences would be catastrophic if the data were not available as soon as possible In a complaint filed with the U.S District Court on Wednesday, Roche said it hoped the court would force Amgen to provide all the data needed by Roche experts and set a deadline for resolving patent disputes At the same time, Roche requested that Amgen be banned from selling the bio generic until the legal dispute was resolved What supports Roche's tough demand is a bill called biological price competition and innovation act (hereinafter referred to as bpcia) In order to promote cheaper bio generic drugs to the market, on the one hand, the bill allows generic drug producers to take advantage of most of the development work done by the owners of innovative drugs, but also provides the latter with a way to protect their patent rights According to bpcia, the biosimilars manufacturing / sponsor, after submitting the simplified biological product license application (a-bla) to the biosimilars for acceptance by FDA, needs to send the a-bla application submitted to FDA and the description of the production process of the biosimilars to the owner of the innovative drugs within 20 days Innovative drug owners will have 60 days to organize experts to review and determine possible violations The innovation in this case needs to be owned by the owner Roche said that Amgen only provided the a BLA and called it all the required materials For this act, Roche accused Amgen of "changing face too fast" in the bio generic patent dispute, and pointed out that the last time Amgen's own bio medicine was infringed, its attitude was totally different In the complaint, Roche said that when faced with the challenge of biopharmaceutical biosimilars, Amgen had said that "if the applicant only provides its abla, the patent owner will not be able to fully protect himself, because many important details about the product are usually omitted" Biosimilars are new even in the United States So far, only four drugs have been approved by the FDA The first one, the generic drug of Anjin's neupogen, was approved two years ago This new field often involves billions of dollars in sales, and the industry is waiting for the further regulation of relevant laws and regulations One such case has been appealed to the United States Supreme Court Unlike this dispute, the Supreme Court will decide in the case involving Amgen and Novartis whether or not applicants for biosimilars can be completely exempted from the bpcia information exchange agreement and, if so, what kind of compensation must be provided to innovative drug owners Another problem exposed in this case is that, according to the regulations, applicants of bio generic drugs need to wait for 6 months after notifying the owners of innovative drugs The previous case believed that applicants must obtain FDA approval before formally notifying the opponents, but Novartis believed that this notification process should be started early in the research and development Otherwise, the extended time in the middle would become the ownership of innovative drugs He made a windfall In this case, Roche hopes that the hearing and court decision can be launched as soon as possible, because the time for sniping into the generic drug application is not long According to the latest financial report, Roche's sales volume in 2016 was chf50.576 billion, an increase of 4% year on year, and the sales revenue of pharmaceutical business was chf39.103 billion, of which Avastin, as one of the trump brand anti-tumor drugs, contributed 17% to the revenue of pharmaceutical business (sales volume was chf6.783 billion).