PHARMACEUTICALS
Safe & effective ?
Under FDA regulatory policy , a generic drug must demonstrate :
• Pharmaceutical equivalence ( with the same active ingredients and concentration )
• Bioequivalence ( 80- 125 %), leading to the same bioavailability as a branded drug , i . e . it must reach the blood stream at the same concentration ( Figure 1 )
• Safety & effectiveness
Global generics
ADC
Biosimilars
Diversified portfolio market segment in which the rival is perceived as underperforming
• Financial strategies , which comprises two approaches : ‘ Pay to delay ’ by paying generics companies not to launch or delay launching generic drugs ; and the ‘ authorised generics approach ’, by selling a drug they are already making under a different name , effectively extending their monopoly for another six months
In certain cases , generic drugs are not same as brand name drugs , which is why the answer to the first question about whether they are as safe and effective is ‘ Not always ’. For example , the FDA does not require generics to have exactly the same inert ingredients , so patients may develop allergies towards the inert ingredients in them . Similarly , in some narrow therapeutic index ( NTI ) drugs , the drug concentration may differ from one generic to another . For therapies for preventing blood clots or seizures , keeping heartbeat normal and treating low thyroid activity , it is safest to use brand name drugs . Doctors often indicate this by writing ‘ Do not substitute ’ on the prescription . In October 2012 , four years after the FDA dismissed consumer complaints that the generic antidepressant Budeprion XL 300 was less effective than GSK ’ s original drug , Wellbutrin XL , new data showed that Budeprion XL 300 does not release its key ingredient correctly . As a result , the agency asked Teva Pharmaceuticals to halt shipments of its generic extended-release bupropion . There are several incidences of generics being recalled where the drugs or additives were sub-standard , tainted or adulterated with toxic contaminants . In 1986 , 14 patients died from taking a common feverreducing medication . An investigation later revealed that the pills had been formulated with industrial rather than
Figure 2 – Future of generics industry
medicinal glycerol . This contained 18.5 % diethylene glycol , three times the lethal dose . In another notable instance in 2008 , heparin acquired from outside the US was recalled because it had been deliberately contaminated with oversulfated chondroitin sulfate . Nearly 100 people died before the contamination was identified and the material recalled . This led the FDA to introduce an additional quality control step , a polymerase chain reaction test technique , for the approval of generic heparin .
Pharma strategies
Pharmaceutical companies have adopted multiple strategies to combat generics . These include :
• Defensive strategies , like brand defence , highlighting the advantages of their product over competitor drugs , including generics
• Proactive strategies , notably anticipating generic competition before patents expire and combating them by filing lawsuits against generics companies in order to retain market share
• Competitive strategies , such as a flanking attack in which one company attacks another in a weak spot , usually by focusing on either a geographic region or a
Outlook
In the last couple of years , the FDA has approved more than 2,000 generic drugs . The US market is projected to witness strong growth to $ 239.5 billion by 2026 as branded drugs lose patent protection . In 2021 and 2022 alone , 21 major brand name drugs will go off-patent . Over the last two decades , there has been also tremendous growth and development in biologics . The US and European biologics markets are currently worth about $ 60 billion / year and a rapid expansion of the number of generic biologics is anticipated in the next few years , driven by over $ 80 billion worth of branded biologics going off patent . Rising awareness of biosimilars owes something to promotion by governments as well as by private organisations . Large pharmaceutical companies are making deals in the generics space and focusing much of their attention on generics . The old saying , ‘ If you can ’ t beat them , join them ’, has become a reality . Generics are here to stay and grow . They will continue to play a critical role in making patient care more affordable and , for the most part , are just as safe and effective . •
Dr Magid Abou Gharbia
TEMPLE UNIVERSITY k + 1 215 707 4949 J magid . abougharbia @ temple . edu j www . moulder . temple . edu
JUL / AUG 2021 SPECCHEMONLINE . COM
23