Medical network - on January 5
Approval number of drug a new low for five years
In 2016 (as of December 30, 2016), a total of 868 drugs by the us food and drug administration (FDA) approved, overall drug approval number than in previous years have decreased significantly, and new drug approval number also hit a five-year low. However, approval number of biological agents of the calendar year. Approved NDA this year a total of 104 new drugs, including 14 new molecular entity (NME) drugs. Approval of biological products (BLA) 12, all three of these creatures is intriguing generics, occupy the 25% of BLA drugs approved amount, have been blowout phenomenon, it is bound to global biopharmaceutical market has brought a lot of intensity.
Figure 1 data source: China's pharmaceutical industry information center, monitoring of drug research database (CPM)
Biosimilars, will drive the change of the global market
2016 is the first year of biosimilars, as the Sandoz production Zarxio (filgrastim - SNDZ) as the first biosimilars for FDA approal, biosimilars was started in 2015 formally to the largest pharmaceutical market in the United States, and in a gusher situation this year, has been officially approved by FDA three varieties listed, and another three in the process of waiting for approval. Approved this year listed three biosimilars are respectively Remicade ® (infliximab) a biosimilars Inflectra, Pfizer by the United States and South Korea self (Celltrion) joint development group company, is approved in April 5, became the first biosimilars monoclonal antibody, used in rheumatoid arthritis, psoriasis, inflammatory disease; Sandoz development Enbrel (etanercept) biological similar medicine Erelzi (etanercept - SZZS), used in the treatment of a variety of inflammatory diseases, a third biological similar drug is approed by FDA; The last one is into the company's Amjevita (adalimumab - atto, Ada wood single resistance), can be used for abbvie branded Humira (merlot, common name: adalimumab, Ada wood single resistance) all indications. Amgen announced last year, is developing generic drugs of nine blockbuster, and plans to start the product to the market in succession in 2017. Amgen said that these products will bring more than $3 billion in annual sales. Amjevita is one of them!
These biosimilars branded medicines are listed on the blockbuster drugs, set a good sales performance, as these biosimilars listed, will inevitably lead to changes in the global pharmaceutical market pattern, Remicade ® (infliximab) biosimilars Inflectra already for Remicade ® brought no small impact on sales, fell by 4% last year. And the United States as the world's important medical market, his biological for examination and approval of generic drugs policy for this kind of medicine enterprises to provide useful reference value, such as evaluation of bioequivalence, patent evade, clinical indications, etc.
Table 1 data source: China's pharmaceutical industry information center, comprehensive database PDB drugs
The FDA's new drug approval work effective cleansing
The FDA's drug approval to accelerate this year, the effective cleansing progress in breakthrough treatment determination, priority review, fast channel of examination and approval and the status of orphan drugs are important strategy of the FDA's accelerated approval this year. CPM database according to the statistics show that in this year's approval of new drugs, 32% (6) drug therapy as breakthrough, 68% get priority review (13), 37% (7) for orphan drugs, for the new drug research and development of innovative drugs to market and clinical application of orphan drugs are the important meaning.
Hot field of new drug approvals, blockbuster drugs emerge in endlessly
In 2016, from the point of approval of new drugs to treat field distribution, the nervous system drugs, anti-infective drugs and anti-tumor drug approval number, account for more than 50% of the total number of approval.
In 2016 the FDA approval of new drugs to treat field distribution
Figure 2 data sources: China's pharmaceutical industry information center, monitoring of drug research database (CPM)
It is worth mentioning that the blockbuster drugs are:
Tecentriq antitumor drugs, genentech (roche subsidiary) research and development of atezolizumab injection for the treatment of bladder cancer drugs, is approved by FDA first PD - 1 / PD - L1 inhibitors. Because of its in patients with lung cancer after curative effect is distinct in the third phase of clinical trial, on October 18, again to obtain new indications, approved by FDA blockbuster drugs for non-small cell lung cancer therapy.
Zepatier anti HCV drugs, American Merck &co., with 4 - in accordance with the SiWei (Grazoprevir - Elbasvir) oral preparations, for genotypes 1 and 4 (GT - GT - 1, 4) chronic hepatitis c virus (HCV) infection treatment. Is gilead Harvoni and abbvie Viekira after approved listing of the world's third breakthrough c cocktail therapy.
Vencleta antitumor drugs, abbvie company treat chronic lymphocytic leukemia venetoclax oral tablets, used in the treatment of chromosome 17 p gene deletion of chronic lymphocytic leukemia patients, is approved by FDA first B cell lymphoma - 2 (BCL - 2) inhibitors.
Nuplazid Parkinson's drug resistance, biological pharmaceutical companies in the United States Acadia Pharmaceuticals to launch the first approved for the treatment of Parkinson's disease (PD) patients experienced mental symptoms such as hallucinations and delusions.
Soft tissue sarcomas Lartruvo new drugs, it is 40 years since the first treatment of soft tissue sarcomas breakthrough drugs, with more soft than star combination therapy of adult soft tissue sarcomas, r&d and production by lilly, through rapid review channel in October 19th, approved by the FDA. |
