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Figure 2. Comparison of NDAs approved month-to-month during 2015 and 2015
% "! "% #! #%
Figure 4. Proportion of large versus small molecules in NDAs
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Figure 2 shows the comparison of NDAs approved in 2014 and 2015 over the months. In the beginning of 2015, the number of NDA approvals was more compared to 2014. It is interesting to note that during the months of May and June, fewer NDAs were approved in both years. In the last quarter of the year, more NDAs were approved in both years.
A dosage form can be a critical parameter for any product. Liquids as a category represents injections (intravenous, subcutaneous, intra- muscular etc.), oral liquids (solutions, suspensions, emulsions etc.), electrolyte replacement solutions, ophthalmic, nasal or otic drops etc. Tablets and capsules contribute to a majority of solid dosage forms.
Figure 3 shows the number of dosage forms approved in the year 2015. In the year 2015, the highest numbers of NDAs were approved for liquids. The next popular dosage forms were tablets and capsules. Some other dosage forms such as powder, topical gel, foam, intrauterine device, buccal fi lms, granules, were approved in fewer numbers. An overall look at the trend for 2015 shows an increasing trend towards developing novel dosage forms like gels, foam or fi lms in the future.
In recent years, there has been an increased interest in large molecules owing to advanced research for diseases like cancer. For the purpose of this article, large molecules were defi ned as those with molecular weights over 1000 Daltons. Approximately 30% of total NDA’s approved in this year were large molecules while the remaining 70% were small molecules (Figure 4). A considerable number of large molecules (~30%) were monoclonal antibodies and other biomolecules, which were primarily used for treating cancers and hormonal disorders. The percent of NDAs approved for large molecules in 2014 were 39.9%, slightly
Figure 3. Number of formulations approved in the year 2015 based on dosage forms.
higher than in 2015. The majority of large molecules are used to treat cancer, diabetes and blood related disease conditions.
It was observed that many big companies applied for a number of NDA’s and obtained approvals. Figure 5 represents the companies with three or more NDA approvals. It is interesting to note that big pharmaceutical companies like Pfi zer and Genentech received only four and three NDA approvals, respectively. Novartis ranked top among all the pharmaceutical companies with ten approvals. Bristol-Myers Squibb and Boehringer Ingelheim Pharmaceuticals, Inc. ranked second with seven NDA approvals each. Some other big companies like Teva, Celgene Corporation, Regeneron Pharmaceuticals Inc., Allergen etc. received approvals for less than three NDAs.
Another important scenario to review is the number of NDAs reported for diff erent disease condition. Figure 6 depicts a bar-chart listing the number of NDAs approved for various medical conditions. The majority of NDAs were approved for various cancers (lymphoma, leukemia, melanoma, lung cancer, neuroblastoma, breast cancer, thyroid cancer etc.), which was about 20% of total NDAs approved in the year. Management of schizophrenia, seizures, Parkinson's, epilepsy, depression, opiate dependence and overdose, multiple sclerosis and some CNS stimulants were classifi ed as CNS disorders. Approximately
Figure 5. List of companies with 3 or more NDA approval in 2015
Pharmaceutical Outsourcing | 40 | July/August 2016
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