Generics :
Here to stay
Dr Magid Abou-Gharbia , Laura H . Carnell Professor and founding director of the Moulder Center for Drug Discovery Research at Temple University , looks at the impact of generic drugs on patients and the pharmaceutical industry
My lecture at Chemspec Europe 2019 in Basel covered the current challenges facing the pharmaceutical industry and the facts about generic drugs . It addressed the key question for patients , ‘ Are generic drugs as safe and effective as branded drugs ?’ The lecture generated a lot of interest during and after the event . I received several communications and some asked for additional information on the impact of generics on patients and the pharmaceutical industry , and the future of generics . Therefore I chose this subject for this article . The pharmaceutical industry is undergoing an unprecedentedly difficult time and facing enormous challenges . These include : its tarnished image ; declining efficiency ; fewer ‘ blockbuster ’ drugs being developed ; patent expiries on key drugs ; fierce price competition from generics ; mergers and acquisitions ; and high regulatory hurdles . These challenges have been further exacerbated by the economic downturn and the US healthcare initiative . To face these current grim realities , pharmaceutical companies have adopted new strategies aimed at restoring public trust and confidence , addressing declining productivity and cutting costs , while ensuring that they
Figure 1 – Examples of bioequivalent ( a ) & non- bioequivalent ( b ) generics
bring a steady stream of innovative therapeutics to patients in the three pharmaceutical platforms : small molecules , biologics and vaccines . The pharmaceuticals market is expected to register a compound annual growth rate of 4.7 % from 2019 to 2026 , to reach $ 1,733 billion in value . However drug discovery and development is a costly and lengthy process . Pharmaceutical companies spend on average about $ 1 billion - and in certain disease areas over $ 2 billion - to bring a new drug to market . The chances of a discovery compound reaching significant revenue are less than one in 10,000 , while it takes on average seven to ten years to bring a new drug to market . With a patent life of only 20 years , companies only have a limited time to recuperate development costs before patent expiry and the launch of competing generic drugs . The growing use of generics is among the key challenges facing the pharmaceutical industry . Just 15 years ago , generics were about 50 % of all filled prescriptions in the US ; now they are almost 90 %. The major reason for this is simply that they cost about 80-85 % less than branded drugs . This brings us onto two main questions around the use of generics . One relates to patients : Are generics as safe and effective as branded drugs ? The other - What are pharma ’ s strategies for combating generics ? – relates to the industry as a whole .
22 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981