Dr. Nimita Limaye
Share
  •  
  •  
  •  
  •  

Pharmaceutical companies need to embrace disruptive innovation to accelerate the time to market of new and effective drugs.

The Food and Drug Administration (FDA) has approved 1,453 drugs as of December 31, 2013, and currently more than 90 companies have approved New Molecular Entity (NMEs). The number of NMEs approved on an average by the FDA was as low as four per year in the 1950s, but gradually increased to 10 and then 20 NMEs per year, reaching a peak of 55 NMEs in 1997. In 2012, the number was 39 and this dropped to 27 in 2013. This was despite the Breakthrough Therapy Designation (BTD) introduced by the FDA to speed up the arrival of major therapeutic advancements. The European Medicines Agency (EMA) in contrast, approved 35 NMEs in 2012 and 38 in 2013, a little more than the FDA. However, 74 percent of the first-in-world approvals have come from the FDA.

While in most of the cases the decisions of FDA and EMA are similar, they differ in cases such as those related to oncology therapies. For instance, Avastin was approved in combination with Paclitaxel by the EMA for the treatment of metastatic breast cancer. However, the FDA withdrew its approval as it did not see the overall survival benefit and high toxicity profile. Both the authorities recognized PFS as a likely surrogate end-point. On the other hand, the EMA did not approve Avastin for the treatment of glioblastoma as it was not satisfied with the efficacy of the data generated from phase II trials, whereas the FDA gave it an accelerated approval.

Pfizer has received the maximum number of NME approvals (198), almost twice that of Merck (106) and Novartis (98). Yet, today, big pharma is struggling, with barely twelve NME approvals per year across the twelve large pharma companies that include GSK, J&J, and Roche.

Key innovation is in the biologics space, andMid-size pharma/biotech companies such as Gilead Sciences, Celgene and Biogen Idec are paving the way for innovation in biologics. R & D models have varied from ‘the chain of pearls’ biotech acquisition strategy of Bristol Myers Squibb to the decentralized, but end-to-end Therapeutic Area (TA) integrated model of J&J and the hub and spoke model of Roche.

Regulatory approvals are also slowing down across the globe. In 2010, 224 new drugs were approved for marketing in India, whereas only 35 were approved in 2013. The clinical trials approved by the Drug Controller General (India) DCG (I) also fell from 529 in 2010 to 253 in 2012 and 107 in 2013.

Thus, given the scenario, there is an urgent need for a change in approach.

What is your organization’s strategy in introducing new and effective drugs?


Share
  •  
  •  
  •  
  •