On July 4, Zydus Lifesciences said in a regulatory filing that it has received tentative approval from the US Food and Drug Administration (USFDA) to market generic Azilsartan Medoxomil tablets used to treat high blood pressure. In June, the company and Dr Reddy’s also announced a licensing agreement for co-marketing of Pertuzumab biosimilar, a critical treatment for breast cancer. This was developed in-house by the research team at the Zydus Research Centre (ZRC), and will be marketed by Zydus under the brand name Sigrima and Dr Reddy’s will market it under the brand name Womab.
The company has a diversified portfolio of differentiated products in generics, complex generics, biologics and new chemical entities (NCEs). Its focus on R&D has enabled them to maintain a steady pipeline of novel molecules and biosimilars. In 2021, Zydus launched Trastuzumab Emtansine, the first antibody drug conjugate (ADC) biosimilar and a highly effective drug for treating both early and advanced HER2 positive breast cancer, under the brand name Ujvira. As part of its innovation efforts, the company has already launched in-market brands Lipaglyn and Bilypsa (Saroglitazar Magnesium) for multiple indications such as diabetic dyslipidemia, hypertriglyceridemia, NASH and NAFLD; and Oxemia (Desidustat)—its second NCE—for the treatment of anaemia in chronic kidney disease (CKD) patients both on dialysis and not on dialysis.
As part of the Indian Pharmaceutical Alliance’s 9th edition of the Global Pharmaceutical Quality Summit 2024, Pankaj Patel, chairman of Zydus Lifesciences, spoke about the need for a shift in mindset to better quality standards, why innovation is the future and more. Edited excerpts:
When I was a young boy, a relative from the US came to meet my father, who used to run our pharmaceutical company. I clearly remember this relative asking my father: What are you concerned about? He said, “I have only one concern: ‘chalshe’, ‘chalega’, ‘hota hai’, ‘it's okay’. These are the kind of words that should not be in our dictionary.”
The day we adopt this mindset in maintaining quality standards, India can achieve anything. We cannot settle for anything that is mediocre. And using technology as an enabler for improving quality standards is going to be very important.
We need to work closely with universities to make sure that freshers are trained properly, and industry-ready. Using digital learning tools, as well as some practical learning—such as creating small factories, within the factory to make sure they are trained properly.
But more importantly, the learning process should never stop. Quality is a journey, but continuous learning is also a journey. This is the approach we should keep in mind to develop our talent pool.
Manufacturing has evolved immensely over the last 10 years, including advancements in technology and changes in operational practices within plants. The Indian pharmaceutical industry has seen a lot of capability building.
But the future is innovation. I strongly believe that it is going to take the industry to the next level from where we are today. Our company has two innovative products that are approved in India. The first one has already completed phase 2, and phase 3 recruitment in the US. Hopefully, it will also have a USFDA approval one day to prove that ‘Yes, India can develop novel therapies for the world’.
Secondly, biosimilars are the future. This is where the Indian pharmaceutical industry is growing very fast. We can proudly say that we have the only ADC drug—antibody-drug-conjugates, which combine chemotherapy and targeted therapy to treat certain blood cancers and cancerous tumours—in the world; it is a biosimilar and produced in India.
This is just the beginning. There is a lot more for the industry to do on the innovation front from generics to novel drugs and biosimilars to novel biologics. I’m confident that the last decade was ours, but the next decade will be even brighter for India.
This article was originally published on Forbes India
