Updated: Jul 22
In an earlier blog post I wrote about how I accidentally got into Angel Investing through an investment in a Biosimilars Startup – GeneSys Biologics. In this post, I dive into the rather complex world of Biosimilars, try to demystify them, explain why Insulin Biosimilars moment to shine has arrived and how it is going to be transformational for GeneSys Biologics.
Pic credit: Trial Site News
Biologics and Biosimilars explained
Biologics as you'd know are medicines extracted from a variety of natural sources—human, animal or microorganism—and include a wide range of products such as vaccines, blood components, gene therapy, tissues and recombinant therapeutic proteins. In contrast to traditional small-molecule prescription drugs that are chemically synthesized, Biologics are large-molecule products that involve complex research, development and manufacturing processes.. Biologics are innovative treatment options for patients affected by debilitating and life-threatening diseases; however, they are often associated with high costs and limited patient access.
A Biosimilar is a safe, effective and less-costly biologic medicine that is highly similar to a previously approved Biologic medicine (known as a “reference product”) currently on the market. Biosimilars have scientifically comparable quality, safety and efficacy to their reference product. Biosimilars are important because, much like generic drugs, they have an opportunity to create competition in the market and expand patient access to critical medicines.
Biologics and Biosimilars simplified; Nature Video
The Current Insulin Landscape
The global demand for Insulin market was valued at approximately $30 billion in 2018 and is expected to generate revenue of around $59 billion by end of 2025, growing at a CAGR of around 9.5% between 2019 and 2025. International Diabetes Federation (IDF) reported that around 425 million people across the world suffer from diabetes. This shows that the rising prevalence of diabetes is propelling growth in the market. In developed pharmaceutical markets such as the United States, the insulin space is competitive, but it is dominated by three key players: Eli Lilly, Novo Nordisk, and Sanofi. Over 90 percent of the global insulin volume in 2018 was supplied by these three insulin manufacturers. Of the growing diabetic population in the United States, roughly 8.3 million people require insulin to regulate blood glucose levels, and it is estimated that worldwide Insulin use will increase 20 percent by the year 2030.
Competition in the Insulin market has been limited for several reasons: Products are not interchangeable, there is a near monopoly in the U.S. market, and no regulatory pathway existed until recently to allow Biosimilar products to create generic-like competition for Insulin. However, by the end of 2020, nearly all existing patents for insulin products will have expired and a regulatory pathway for Biosimilar Insulin in the United States will be available. These changes should facilitate downward price pressure.
Pic credit: Diabetes Daily
Why is Insulin so expensive?
The ‘big three’ insulin producers – Eli Lilly, Novo Nordisk and Sanofi dominate more than 90% of the world insulin market by value. Often only one of these companies supplies insulin in a country, which means they more or less hold a monopoly there and can set prices as they wish. Secondly there is no generic alternative available as Insulin is a therapeutic biological product (biologic), rather than a chemically synthesized molecule. This means it cannot be made as generic in the same way as other drugs. Ever-greening on patents by taking advantage of loopholes in the system to make them last much longer than their terms is another cause. And finally, the most important reason is price fixing. The below graphs pretty much say it all and several lawsuits alleging some form price-fixing are currently are in the works.
Graphs credit: Business Insider
New FDA draft guidelines for Insulin Biosimilars - Interchangeability
New draft guidance released in November 2019 from the FDA for Insulin Biosimilars, potentially allow for cheaper near-identical versions of these Biologic drugs to be interchanged with the originator. Therefore now an Insulin Biosimilar may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product. This is in line with how most patients currently receive their generic medicines.The new FDA draft guidance is good news for patients in the US looking for cheaper diabetes medications, and for the Biosimilar manufacturers who under current rules couldn’t compete directly with the more expensive branded drugs. It also brings the US in line with the European Medicines Agency, which introduced a Biosimilar approval pathway first and has already approved Biosimilar Insulins.
FDA Draft Guidance on Insulin Biosimilars, Interchangeable Insulins released in November 2019 are transformational. Pic credit: Pharma Phorum
GeneSys – metamorphosis from an incubator to a global Insulin Biosimilars player
GeneSys Biologics was incorporated in 2014 after a team of talented and hugely experienced Scientists approached our Angel Group with this world-class project and got funded. The beginnings were humble, starting at an incubator in BITS Pilani, to now residing in its own glittering 5-acre campus in Genome Valley, Hyderabad. The integrated drug development facility makes Insulin Biosimilars across the value chain from research and development to commercial manufacturing. The facility also contributes towards the company’s global clinical programme and caters to the future commercial requirements of India and other emerging markets. This facility also houses a research and development center, quality analysis and quality control labs. The unit complies with WHO Good Manufacturing Practices (GMP) norms.
The sprawling GeneSys Biologics campus at Genome Valley, Hyderabad
GeneSys Biologics has a portfolio of six Insulin products and will discover, develop and deliver these products for the global markets. The company is targeting a potential market size of $30 billion once its products are commercialized. The new draft FDA guidelines where the word “interchangeable” got incorporated along with Insulin Biosimilars is game-changing and wouldn’t have come at a better time for GeneSys Biologics as they enter into their clinical development pathway. This will also result in huge cost savings in Phase 3 (>$20 Million per product) and more importantly, ~18-24 months’ time savings for each Phase 3 trial.
Biosimilar medicines have the potential to offer healthcare systems huge savings estimated in the range of $250 billion over the next 10 years. They represent a cost-effective alternative to the originator drugs and are expected to bring down prices in the range of 30-40%. This in turn makes critical, life saving medicines affordable and accessible to a wider population and thereby creating a societal impact. GeneSys Biologics has been funded by an Angel Group in Hyderabad and I'm immensely proud of its journey so far and look forward to the company transform into a leading global Insulin Biosimilars manufacturer in the near future.
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