How an IIT team is aiming to make expensive biotech drugs more affordable
When 30-year-old HR professional Rekha Verma (name changed) was diagnosed with breast cancer in 2012, she couldn’t afford ‘wonder drug’ trastuzumab.
She prayed that surgery, chemotherapy, and radiotherapy would be enough.
Last month, she relapsed and was once again advised to use trastuzumab along with chemotherapy. The drug’s price had halved since 2012 and cheaper versions were also available.
Still, they were too expensive for Verma— her family’s combined monthly income was at least Rs 50,000 short of the monthly treatment cost and trastuzumab’s price accounted for a major chunk. Her medical insurance didn’t cover this drug, she said.
While Verma’s employers decided to cover the cost of her medication, other patients like her may not be as lucky, she said.
Trastuzumab, a drug developed through bio-engineering, currently has a maximum retail price of Rs 52,000-58,602 for a 440 mg vial, depending on the brand, according to the National Pharmaceutical Pricing Authority.
The number of vials required in treatment varies and patients are sometimes able to negotiate discounts.
“I know people who had to even sell their house to get the medicine,” said Verma. “For average, middle-class families like mine, it’s difficult to even think about getting such medicines because they’re so expensive.”
A team of professors and students from the Indian Institute of Technology Delhi has been working on just this aspect for the past three years: how to make life-saving biotech drugs affordable. They are a step closer to this goal today, having developed technology to lower prices of such drugs by targeting one of the costs to make them.
“Biotech drugs are super-expensive,” said Anurag S Rathore, a professor at IIT’s Department of Chemical Engineering who spearheads the project by its Centre of Excellence for Biopharmaceutical Technology.
On average, biotherapeutic products cost 20 times more than their pharmaceutical counterparts, according to Rathore.
Such products are complex in composition and equally complicated to make, often involving expensive machinery and equipment—one reason there isn’t adequate competition in this segment, industry experts said.
Unlike conventional drugs that are made from chemicals, biotech drugs or ‘biologics’ are made inside living sources like bacteria or cells of plants, animals or humans. In the simplest terms, such drugs are proteins, sugars, nucleic acids (DNA or RNA) or a combination of these.
Some biologics used in cancer treatments carry hefty price tags of over Rs 1 lakh for a single course and a patient requires several courses to successfully complete treatment. New immunotherapy drugs can be priced higher.
Copies of original biologics, called biosimilars, can only offer a 20-30% reduction in price if the market isn’t competitive enough, according to some experts.
“Such drugs are competitively priced, yet still expensive,” said Sachin Almel, a consultant medical oncologist at Hinduja Hospital and Medical Research Centre in Mumbai.
Yet, biologics are imperative and often the most effective option for chronic and life-threatening conditions without any available treatment, according to the US Food and Drug Administration. Even some biologics for conditions with existing treatment options are crucial in improving the effectiveness of these therapies, claim medical professionals.
Almel has seen cure rates of his lymphoma patients improve by 20-25% after introducing cancer biologic rituximab into their treatment regimen. “Because of this, rituximab became a very attractive option to offer to my patients,” he said.
The IIT team proposes to encourage more companies interested in entering the biotherapeutics space by drastically reducing the cost of manufacturing these medicines.
“If we enable more domestic manufacturers to make the drug, then the competition will result in a price drop,” explained Rathore.
Most companies today manufacture biologics in batches—a system that is time-consuming and expensive, according to the team at IIT. The process of ‘tricking’ microorganisms or cells into producing the biologic drug through genetic engineering involves various stages and can take weeks. Until one lot (a set of batches) of the protein created is separated and purified, companies cannot begin making subsequent lots. This is how they end up losing time and money, according to the IIT team.
The IIT Solution
Drawing from the way the oil and natural gas industry and FMCG companies manufacture their products, the IIT team figured out how to continuously churn out such medicines, a process that could cut the cost of manufacturing certain types of biologic drugs by as much as 70%.
Using IIT’s system, companies can produce up to 15 times more medicine in the same time, according to Nikhil Kateja, one of the PhD students involved in the project from the start.
“If there is no shutdown time, you can make more protein in the same time – that’s the biggest advantage,” he said.
The technology is also expected to assure consistency in the quality of the drugs produced, according to Vishwanath Hebbi, a PhD student participating in the project.
“When we study molecules already in the market, we see variations in the quality of the same molecules because they were made in different batches,” he said.
Hebbi developed a sampling device that can be installed throughout the system as well as an online tool that would cut down the time taken to analyse each sample for impurities to as little as four minutes from 30 to 70 minutes without any need for manual intervention.
IIT’s technology is expected to help more companies manufacture crucial biosimilars, including those that help a chemotherapy patient produce white blood cells to reduce the risk of contracting infections.
Apart from this, the team is tweaking its technology to continuously manufacture monoclonal antibodies such as trastuzumab and bevacizumab that stimulate the patient’s immune system to attack specific kinds of antigens, including cancer cells. Monoclonal antibodies constitute an increasingly larger share of biotech therapeutics for diseases such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
The technology has caught the attention of biotech drug makers Bengaluru-based Biocon and US-based Paul Life Sciences, which, along with some government departments, have given IIT Rs 15 crore to reconstruct its tiny prototype in a 1,600 square-foot lab on campus. The institute expects companies to test the system when the larger setup is complete in a year.
“All the large companies in India are, to some extent, interested,” said Rathore, adding that talks are on with one company for a potential license.
Manufacturing alone accounts for up to 30% of the total cost borne by some biologic drug makers, according to an industry executive who spoke to ET on condition of anonymity.
“Technology like this could possibly shave off a majority of this cost,” the person said.
Innovation-led biotechnology currently requires heavy investment in capital, research, and intellectual property, making it a “high risk, high-reward” business that restricts the field to a handful of serious players, according to Narendra Chirmule, Biocon’s head of R&D. “For an Indian multinational corporation… the manufacturing cost is the most significant cost, other than overhead costs,” said a spokesperson for Ahmedabad-based Intas Pharmaceuticals.
At the same time, the transition to continuous manufacturing will depend on demand for the drug, said the spokesperson. “Increasing production as per the demand would help achieve better economies of scale and help reduce the price of drugs to some extent initially and substantially in the long term,” the spokesperson said.
However, merely reducing the cost of manufacturing a biologic drug may not increase access to treatment for patients in lower-income brackets, said Department of Biotechnology Secretary K Vijay Raghavan.
“Once you have a product that is already designed and being made in a batch process, a continuous process, which is more efficient, it will be invaluable in bringing down costs. Now, how this translates into prices of biosimilars is another complex matter,” he said. “Increasing affordability for every patient is more an overall public healthcare system issue that is not specific to just biosimilars.”
Innovative technologies, use of automation and machine learning or artificial intelligence and bioinformatics could help bring down the cost of therapy to patients further, added Biocon’s Chirmule.