Global scientists have urged pharmaceutical companies, governments and academic institutions to make monoclonal antibodies used to treat life-threatening diseases available to people living in low- and middle-income countries (LMICs).
Monoclonal antibodies are lab-made proteins that act like natural antibodies in fighting disease. Derived from human immune cells, these proteins act specifically against targets ranging from cancerous cells to viruses and bacteria, or alter precise immune pathways to augment a person’s ability to fight disease.
At least 120 monoclonal antibodies have been approved in the 30 years since the first one was licenced to prevent and treat several chronic and life-threatening diseases, including many cancers, autoimmune disorders and some infections, including the coronavirus disease (Covid-19).
Around 80% of licensed monoclonal antibodies are sold in Europe, the US and Canada, with only 20% sold to countries that account for 90% of the world’s population.
Availability and affordability are two of the biggest barriers to availability in LMICs, said the report titled Expanding Access to Monoclonal Antibody-Based Products: A Global Call to Action, released by Wellcome, an independent global health foundation, and the International AIDS Vaccine Initiative (IAVI), a non-profit scientific research organisation.
“India is one of the best case scenarios among middle-income countries, but still only a fraction of products available in the US are available in India. In fact no monoclonal antibody treatments for cancer are available in the Indian public health system,” Wellcome said in a tweet.
Building on Covid partnerships
Neutralising antibodies, whether natural or monoclonal, can bind directly to portions of viruses that they use to attach to and enter cells, preventing them from initiating infection. According to the Wellcome-IAVI report, monoclonal antibodies can potentially complement Covid-19 vaccines, especially for those who may not benefit from a vaccine because of age or medical conditions.
If successful, the new approaches and partnerships forged for Covid-19 can set precedents to support increased global access to monoclonal antibodies targeting many other diseases, the report said.
Earlier this week, the US began enrolling healthy adults for two Phase 3 gold-standard randomized, placebo-controlled, double-blind trials to test whether experimental monoclonal antibodies can prevent infection from Sars-CoV-2, the virus that causes Covid-19. The trials are enrolling adults who are at risk of infection due to close contact at work or home with people infected by Sars-CoV-2.
antibodies in India
Last month, the Drugs Controller General of India approved the indigenous psoriasis drug Itolizumab to treat moderate to severe Covid-19. This monoclonal antibody has been manufactured and marketed by Biocon since 2013 for the treatment of patients with moderate to severe chronic plaque psoriasis.
Also ongoing are multi-centric trials to evaluate the standard use of the monoclonal antibody drug Tocilizumab, which is a second-line drug used to treat rheumatoid arthritis. “Tocilizumab is approved to treat moderate to severe Covid-19 patients whose condition is worsening, and the trial will also evaluate whether the drug will prevent the progression of stable moderate disease to severe Covid-19 needing oxygen or ventilator,” said Dr Arvinder Soin, national lead, Indian multi-centre trial on Tocilizumab, and chairman, Medanta Liver Institute, Medanta, Gurugram.
“We have already recruited 138 of 180 patients for the Tocilizumab trial, which is being done across 14 hospitals in 10 cities. The majority have moderate disease, with some severe cases. The trial is going fine,” said Dr Soin. The trial will be conducted in several hospitals in Delhi-NCR (National Capital Region), Haryana, Maharashtra, Uttar Pradesh, Telangana and Tamil Nadu.
Tried and tested
Monoclonal antibodies have dramatically improved cancer survival rates and are being evaluated for their potential to prevent and treat infectious diseases including Ebola, and HIV, but they are among the most expensive pharmaceutical products in the world and inaccessible to most of the world’s population.
“Monoclonal antibodies are used for immunotherapy and antibody drug conjugates to treat several cancers, including melanomas, cancers of the head and neck, urinary bladder, stomach, oesophagus, and stomach, among others. But they are very expensive, with each injection – usually given once every three weeks – priced at around ₹3 lakh. They are not available in the public sector in India,” said Dr Pramod Kumar Julka, senior director, Max Institute of Cancer Care, and former professor and dean, All India Institute of Medical Sciences, New Delhi, who introduced monoclonal antibodies to treat cancer at AIIMS in 2015.
The report proposes four parallel actions to ensure widespread access in LMICs: Increase advocacy and awareness of the life-saving potential of monoclonal antibodies to make them more widely accessible, develop expanded policy and regulatory pathways to increase availability, Invest in and apply new technologies to lower development costs, and establish alternative business models to enable innovative market approaches to promote global access. – Hindustan Times