GERMANY — Evotec, along with its subsidiary Just – Evotec Biologics, Inc., based in Seattle, has joined forces with Sandoz, a division of Novartis, to embark on a long-term technology partnership for the rapid development and subsequent manufacturing of multiple biosimilars.
This collaboration includes the option for Sandoz to non-exclusively license Just – Evotec Biologics’ advanced technology for constructing its fully-owned S.POD facility, similar to Just – Evotec Biologics’ cutting-edge J.POD facilities.
The decision to form this partnership comes on the heels of Novartis’ plan to spin off Sandoz, which was announced last summer as part of the company’s broader strategic review initiated in October 2021. The spinoff is expected to conclude in the second half of 2023.
Under this agreement, Sandoz will gain access to Just – Evotec Biologics’ drug substance development platform and manufacturing technology, enabling Sandoz to expand its existing biosimilars pipeline from 15 to approximately 24 candidates.
Additionally, Sandoz aims to enhance its early-stage biosimilar pipeline through this collaboration.
The partnership outlines a substantial financial arrangement, with Just – Evotec Biologics receiving a double-digit-million upfront payment and future payments of up to US$640 million, contingent on the successful development progress.
The agreement also includes undisclosed payments tied to the progress in commercial manufacturing and the exercise of the S.POD option.
According to Evotec, the partnership’s primary focus is on achieving the highest quality and lowest cost levels by incorporating Just – Evotec Biologics’ data-driven, fully integrated design capability and continuous manufacturing technology (J.DESIGN) into the field of biosimilars.
The development of these biosimilars will be intensified over the next 12-18 months, fostering a highly collaborative environment at Just – Evotec Biologics’ J.POD facilities.
Furthermore, this collaboration establishes a precedent for Sandoz to non-exclusively license Just – Evotec Biologics’ J.DESIGN platform, process development, and continuous manufacturing technology.
Sandoz plans to build an advanced ‘S.POD’ facility later in this decade, with support from the Just – Evotec Biologics team in terms of design, construction, onboarding, and training.
This venture aims to fully unleash the technology’s potential, positively impacting cost, speed, and quality in the field of biosimilars.
J.DESIGN incorporates a range of technologies, including artificial intelligence, machine learning, and intensified and continuous bioprocesses.
The platform is specifically designed to mitigate risks during clinical development, offering flexible capabilities for both clinical and commercial manufacturing within the same J.POD facility. Ultimately, it enables cost-effective commercial supply of biologics.
Sandoz has been strengthening its biosimilars business in recent months. The company has made significant investments in its Holzkirchen, Germany, site to establish a core biopharma technical development hub dedicated to future biosimilar growth.
Furthermore, Sandoz has pledged a minimum of US$400 million to construct a new biologics plant in Slovenia, focusing on biosimilars.
Construction of the biologics plant in Lendava is scheduled to commence this year, with completion expected by late 2026, according to Sandoz.
While biosimilars have gained traction as a viable alternative to branded medicines in many parts of the world, their adoption in the United States has been slower.
However, a biosimilar boom could be on the horizon, considering that the FDA approved six new biosimilar products in 2022 alone.
Moreover, in early 2023, the first of several biosimilars to AbbVie’s blockbuster drug Humira entered the market, signaling a shift in the landscape.
For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.
