學名藥30年好日子已成過去式！ 2017/09/20 出處：財訊雙週刊 第 537 期 作者：夏彌新 美國專利制度對於藥物創新扮演十分重要的角色，
榮景》政府支持＋專利到期 帶動學名藥30年成長 學名藥的開發相較新藥研發費用少，且相關的試驗風險亦較低。
利空》市場供過於求 劣質印度學名藥品大舉入侵 全球最大學名藥廠TEVA最近法說會也說明，
考驗》搶入生物相似藥 一線大廠加入戰況愈形激烈 其實，TEVA或是Mylan等一級大學名藥廠，要取得FDA核
Mylan Announces Global Settlement And License Agreements With Genentech And Roche On Herceptin® Hertfordshire, England and Pittsburgh, PA /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that Mylan has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin® (trastuzumab), which provides Mylan with global licenses for its trastuzumab product. The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan's trastuzumab, the settlement eliminates further patent litigation expenses associated with Genentech and Roche. Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement. Following this settlement and the recent acceptance of Mylan's application for its proposed biosimilar trastuzumab with the U.S. Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S. All other terms and conditions of the settlement and license agreement are confidential. Mylan CEO Heather Bresch commented, "There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world. With 16 biosimilar products in development, we believe Mylan has one of the industry's broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis." Mylan's proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world. In the U.S., Mylan's Biologics License Application (BLA) for proposed biosimilar trastuzumab is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017. Mylan currently markets its trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the U.S.
FDA Approves First Biosimilar for Cancer Treatment Jason Harris Published Online: Thursday, Sep 14, 2017 ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin) developed by Amgen and Allergan, is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients. A biosimilar is a biological product that is demonstrated to be highly similar to an already-approved biological product, and that has no clinically meaningful differences in terms of safety, purity and potency from the reference product. "Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies," FDA Commissioner Scott Gottlieb, MD, said in a press release. "We'll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA's rigorous gold standard for safety and effectiveness."
ABP-215 is approved for: • First- or second-line treatment of metastatic colorectal cancer, in combination with 5-fluorouracil-based chemotherapy • Second-line treatment of metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-
There are several pending applications for biosimilars to treat cancer awaiting FDA consideration, including one for MYL-1401O, a biosimilar for trastuzumab (Herceptin). The FDA is expected to rule on a biologics license application for MYL-1401O to treat HER-positive breast cancer, HER2-positive gastric cancer, and gastroesophageal junction cancer by the end of this year. In July, the FDA's Oncologic Drugs Advisory Committee voted 17-0 to recommend approval of ABP-215. Some committee members were concerned at the time about recommending approval for all 6 indications because all the data presented came from patients with advanced/metastatic NSCLC. They eventually determined that the pharmacokinetic (PK) data and method of action were consistent enough to warrant their support. ODAC reviewed data from a pair of studies, the 3-arm, single-dose PK study 20110216 that compared ABP-215 with US- and EU-approved bevacizumab, and a comparative clinical study, 210120265. The second study compared ABP-215 and EU-approved bevacizumab in patients with advanced/metastatic NSCLC to support the demonstration of no clinically meaningful differences in terms of response, safety, purity, and potency. In the PK study, 68 patients were assigned to ABP-215 and 67 each were assigned to the bevacizumab groups. All healthy male participants (N = 202) received an infusion of 3 mg/kg. Investigators concluded that the 90% confidence interval (CI) for the ratios of geometric mean of AUC0-∞, AUC0-t, and CMAX demonstrated PK similarity between ABP-215 and US- and EU-approved bevacizumab. CMAX was 98.1 (90% CI, 93.7-102.8) between ABP-215 and US-approved bevacizumab, 102.9 (90% CI, 98.2-107.8) between ABP-215 and EU-approved bevacizumab, and 104.9 (100.1-109.9) between US-approved bevacizumab and EU-approved bevacizumab. Study 20120265 was a randomized, double-blind study comparing ABP-215 (n = 328) and EU-approved bevacizumab (n = 314) in patients with advanced NSCLC. All patients received an infusion of 15 mg/kg every three weeks in combination with 6 AUC carboplatin and 200 mg/m2 paclitaxel for 6 cycles. Overall response rate was 39% in the ABP-215 arm compared with 41.7% for EU-bevacizumab (risk ratio, 0.93; 90% CI, 0.8-1.09). There were 2 complete responses in each group, and 38.4% of the ABP-215 group had partial responses versus 41.1% in the bevacizumab group. Duration of response was 5.8 months for ABP-215 (95% CI, 4.9-7.7) compared with 5.6 months with bevacizumab (95% CI, 5.1-6.3). Forty percent of patients in both groups experienced progression-free survival (PFS) events (HR, 1.03; 95% CI, 0.8-1.34). Median PFS was 6.6 months for ABP-215 (95% CI, 6.3-7.9) versus 7.0 months in the bevacizumab arm (95% CI, 6.6-8.2). Trough serum concentrations (Ctrough) were collected on cycle 1 through cycle 4, and cycle 6 pre-dose to describe the PK of ABP-215 and EU-approved bevacizumab. The study was not intended to evaluate PK similarity between the 2 arms, but investigators observed comparable Ctrough and inter-subject variability. Investigators said safety outcomes were similar to the known toxicity profile of US-approved bevacizumab, and there were no meaningful differences in adverse events (AEs), serious AEs, deaths up to 30 days after last treatment dose, or treatment discontinuations. Reported grade 3/4 AEs were 42% in the ABP-215 arm and 44% in the bevacizumab arm. No grade 3/4 AE exceeded a 2% incidence rate. In a press release, the FDA reported that, as with bevacizumab, ABP-215's label includes a boxed warning regarding an increased risk gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal hemorrhage.
