Future of branded drugs in a generic world

According to market research sources, the top 50 pharmaceutical brands come from the top 50 pharmaceutical companies worldwide. Out of the top 10 brands, all are in the declining phase except for Humira and Lanctus. Herceptin is the 9^th ranked brand with a low growth of 3 percent. Remicade (infliximab), Enbrel (etanercept), Rituxan (rituximab) and Avastin (bevacizumab) are brands which will lose patent protection by 2019 in both USA and EU. Etanercept has already lost patent protection in February 2015 in the EU and in 2012 in the US. Predicted declines are for all these antibody drugs are expected as the brands already have ‘copy-cat’ or biosimilar versions already launched or under way in the manufacturing plants of key generic drug players.
 
Humira (adalimumab), which is a tumour necrosis factor alpha (TNF alpha) inhibitor, is prescribed for rheumatoid arthritis, Crohn's disease (digestive tract inflammation), psoriatic arthritis, ulcerative colitis, plaque psoriasis, ankylosing spondylitis (spine infammation), and juvenile idiopathic arthritis (joint inflammation in children) and is one of the widely accepted treatments for RA in particular despite its extensive capacity to cause infections. Humira registered a 17 percent growth in sales value in 2014 which is the highest among the top 10 brands.
 
Herceptin (trastuzmab) is already off patent in 2014 and its decline in value growth is evident with the incoming versions of biosimilars. Herceptin is widely used for the treatment of metastatic breast cancer and stomach/gastric cancer. Lanctus (insulin glargine) maintains a growth of 11 percent because of its ability to manage glucose levels effectively in both type I and type II diabetes.
 
Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) and Sovaldi (sofosbuvir 400 mg), approved in the US, are used for the treatment of chronic hepatitis C virus (HCV) infection in patients with advanced liver disease. This is a brand which has been approved for usage in April 2013 and, therefore, registered a double digit growth in 2014 over 2013.
 
  With the monoclonal antibodies dominating the top global brands and their patent expirations drawing nearer, it needs to be seen as to what these brands and their companies must do in order to revitalise their existing brand and their portfolio. Most of the these ‘aging brands’ have their own exclusive patient help websites where details of the medication schedule, patient help desks, safety and even web/android applications are available for download to make the information accessibility faster to the end user, ie the patient.
 
Patent expiration: The generic factor
Key companies like Amgen, Pfizer, Roche, BMS and Novartis have their bestselling patented brands used for curing life threatening diseases facing patent expirations. The question then arises as to what these companies must do in order to ‘save’ their brands which have acceptability among the payers in the US and EU, despite their declining affordability among the masses due to their pressures on the healthcare budgets of the respective governments. These brands have an acceptance among the existing customers and patients are seldom willing to look for options till there are no better alternatives.
 
It needs to be seen that pharmaceutical companies worldwide are faced with multiple challenges to sustain these brands. They will have to manufacture their patented products for their existing and new users till the molecule reaches the patent expiration stage. The brand value would remain sustained as each prescription of the branded drug yields long term sales. The brand would take a hit in terms of margins and profitability no doubt but its brand value and the resonating equity would remain in the customers mind despite generic drug/biosimilar drug players coming into the picture.
 
The road ahead for pharmaceutical branding
Pharmaceutical branding strategies for older and ageing brands can therefore take the following alternatives to sustain in a competitive market:

• Re-position the brand for alternative indications for the same molecule: Apply for a further patent to increase the brand’s patent lifespan
• Patient education strategies: Online/ website promotions, brand usage help lines/ toll free numbers
• Introduction of novel formulation of the same brand; maybe a farfetched proposition because most of these are injectables
• Introduce new brands with similar efficacies for the same indications as the existing brand and build a portfolio
• Introduce new brands with similar efficacies for new/rare indications
• Shifting manufacturing/production of their old brands to cost effective locations/strike an alliance/joint venture with an off-shore partner and share risk and save costs

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Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/