Analysis of newly marketed drugs in 2018 consisting new chemical entities (NCEs) and new biological entities (NBEs), by drug name, trade name, indication, mechanism of action, companies and country of launch.
- List of new chemical or biological entities with novel mechanisms of action launched during 2018, where the active ingredient had received no prior approval for human use, including vaccines with novel antigenic components, and excluding new drug launches with reformulated or non-NAS moieties, or biosimilars.
* Combination drug, ** Novel mechanism of action
Analysis of newly launched drugs (2018)
In 2018, out of the 68 new active substances (NASs) launched, 7 were vaccine candidates. In addition, over a third of the new drugs launched had orphan drug designation.
- Among the companies with more than one newly approved chemical or biological entities included Array BioPharma, AstraZeneca plc, Eli Lilly and Company, Ionis Pharmaceuticals, Kyowa Hakko Kirin Co., Ltd., Ligand Pharmaceuticals, Inc., Merck & Co., Mylan N.V., Novartis AG, Pfizer, Inc., Portola Pharmaceuticals, and Sanofi S.A.
Pfizer and Merck & Co. dominated the market position, being the only companies to launch four new drugs to the market.
- Pfizer originated and developed three of its novel drug candidates: Daurismo (glasdegib), Lorbrena (lorlatinib) and Vizimpro (dacomitinib), all for cancers, while the antidiabetic Steglatro (ertugliflozin) was developed in collaboration with Merck.
- On the other hand, out of the four new drugs developed and launched by Merck & Co., two of these drugs, the psoriasis monoclonal antibody drug Ilumya (tildrakizumab) and Beova (vibegron) for overactive bladder were in partnership with Sun Pharma Advanced Research and Japan’sKyorin and Kissei, respectively.
Based on the therapeutic area, anti-cancers and anti-infectives groups marketed a total of 17 new drugs each, followed by alimentary or metabolic disorders and neurological diseases class.
- The anti-infectives class included seven vaccines, antivirals and antibacterials. The antivirals included four new HIV therapies, one for hepatitis C, and a rare anti-influenza therapeutic.
- Among the neurologicals class, three were the new calcitonin gene-related inhibitors for migraine prophylaxis, epilepsy and amyloidosis.
In terms of the types of drugs brought to the market, biological drugs accounted for 35% of the total number of launches.
- These included 10 monoclonal antibodies, four vaccines, three recombinant proteins, two cell therapies, two gene therapies, and one antisense oligonucleotide, RNA interference agent, and antibody-drug conjugate.
Geographically, more than 60% the new drugs were launched in the United States alone, followed by Japan, while Germany and China secured 3rd position with four newly marketed drugs indicating highest involvement in R&D activities in these countries.