An ‘Analytical Dynamo’ Poised for More Biosimilars Success

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Its unorthodox name reflecting a somewhat unconventional approach, mAbxience has achieved some significant milestones in its short history, including becoming the only privately-owned company in the world with less than 500 people to have launched a monoclonal antibody biosimilar. “This is not usually a small company game, and mAbxience did it,” says the firm’s Canadian CEO, Emanuelle Lepine.

The company was formed in 2010, when Insud Pharma – the group founded by Argentinians Hugo Sigman and Silvia Gold – acquired small biotech pharmADN and served as the fully-owned biotech arm of the group until March 2022, when Insud reached the coveted milestone of sharing its creation with a global powerhouse by selling 55 percent of mAbxience to Fresenius Kabi.

To understand how the company succeeded as an underdog, one should look no further than its last and current era. The Lepine Era. She joined the company in October 2016 at a time when shareholders were bent on pivoting their ambitions from Latin America to conquer global, more sophisticated, markets. After five years, Lepine says, the mission has been accomplished: mAbxience is now selling its biosimilars in Europe and received approvals from US and Japanese regulators.

… the company gained global recognition during the COVID-19 pandemic after being chosen by AstraZeneca to produce its vaccine for most of Latin America

More than that, the company gained global recognition during the COVID-19 pandemic after being chosen by AstraZeneca to produce its vaccine for most of Latin America. It was a classic case of being in the right place at the right time. mAbxience was opening a new state-of-the-art greenfield biomanufacturing facility in Argentina when the pandemic hit, transferring their own products when the UK-based multinational approached them. “AstraZeneca identified mAbxience as a key CDMO partner because, having great experience in technology transfer, we understand the science and help them improve their own process,” the CEO argues.

 

Hiring a biosimilars pioneer

… mAbxience was a well-hidden secret with a fantastic platform and great potential that needed to be exploited.

Emanuelle Lepine, CEO

Emanuelle Lepine’s biosimilars journey began when Robert Wessman – the Icelandic founder and owner of Alvogen – saw a great opportunity in the sector. By the time Wasserman tasked Lepine with creating a business plan for what would eventually become Alvotech, in 2010, the Canadian executive had already spent more than a decade in the generics industry. She knew what needed to be known about competing with similar medicines.

Lepine was part of the creation of the biosimilars industry at a time when there were few regulations for them. Only the EMA had developed guidelines; the US FDA would follow in 2012. It was all uncertainty. “We did not know if health authorities would accept extrapolation of indications, how to design clinical trials, or how many batches were needed to establish similarity. There was a big cloud of uncertainty, including the question of regulatory authorities accepting single-use bioreactors at a moment when the industry worked with stainless-steel bioreactors,” she recalls.

In only three years, Alvotech went from concept to having six molecules in its pipeline and was opening a new manufacturing plant. When Lepine left, the company had over 200 employees. “It was a real fairy-tale business adventure for me!”

Her move to mAbxience was motivated by a familiar attitude. “mAbxience was one of the pioneering companies that took the risk and went in that direction [betting on single-use bioreactors]. I was convinced that single-use bioreactors were part of the technology of the future because of the ability to control contamination and lower capital expenditure (CapEx).”

Lepine agreed to join the project because the company had already established proof of concept with one product in the market. “I thought that their strategy was quite clever; going small and generating revenue to finance these expensive developments instead of starting from scratch and aiming for the largest and most highly regulated markets… mAbxience was a well-hidden secret with a fantastic platform and great potential that needed to be exploited.”

 

The “clever” strategy

mAbxience – at least before the Fresenius Kabi deal – did not have a vast sales and marketing operation. The company employs a business-to-business (B2B) model, signing partnerships “with the strongest local players” instead of going for regional or global partners. Their bet is on manufacturing competitiveness.

“Unlike Big Pharma players, we develop biosimilars with a generic mindset rather than developing them thinking that they will be branded and marketed at high margins. If you have a generics background, you understand that this is not how it is going to end up,” says Lepine. As biosimilars get more competitive, the “game” of the company is to control development and manufacturing costs to create efficiency-led margins.

But as the company grows, so its ambitions. mAbxience is now leveraging its expertise to enter the innovation arena, currently with two new pharmacological entities in collaboration with universities and companies that wished to use their platform. What will not change, Lepine says, is the B2B model; the intention is to partner with the industry in later stages.

Asked if working on innovative assets could take their focus away from biosimilars, the CEO told HCLS that biosimilars “are complex and require high levels of proficiency in both analytics and characterization, which is not the core of the development of innovative products. mAbxience is an analytical dynamo with all the technology in-house, so it is well equipped to engage in innovative development as well as biosimilars.”


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