Xbrane has signed a non-binding letter of intent with Chinese pharmaceutical firm CR Pharma for the development of Xlucane, its biosimilar candidate to Roche’s blockbuster ‘wet’ age-related macular degeneration (AMD) drug Lucentis (ranibizumab).
The announcement came to clarify a co-development announcement made mid-December by CR Pharma (see here in Mandarin), and according to the Swedish drug developer no terms have as yet been agreed.
“A detailed evaluation of the product, market and local regulatory requirements will now follow along with negotiations regarding commercial terms for a potential final agreement.”
However, Xbrane CEO Martin Åmark told Biopharma-Reporter his firm was looking to bring the Phase III candidate to China to capitalise on the “significant growth potential for VEGF-a [Vascular Endothelial Growth Factor A] inhibitors” driven by the country’s large population.
There has been a biosimilar approval route in place in the region since 2015 when the China Food and Drug Administration (CFDA) released final guidance for the development and evaluation of biosimilars.
According to Asian pharmaceutical business development and regulatory affairs consultancy firm Pacific Bridge Medical, the CFDA’s 2015 biosimilar guidance:
“establishes basic principles for development and evaluation of biosimilars, including recommended studies and quality control.
“Biosimilars should be submitted via the new drug approval pathway, although they will be reviewed according to a separate set of technical criteria. Biosimilars should also have the same amino acid sequence as the reference drug. The reference drug should not itself be a biosimilar — and must be approved in China before starting clinical trials for the biosimilar product.
“It is expected that these guidelines will reduce biosimilar development costs for drug companies. However, approval time for a biosimilar product may not improve; it currently takes an average of five years for an innovative biologic to reach the Chinese market.”
Thus the challenge to bring a product like Xlucane to the market comes with finding a strong sales and marketing partner, said Åmark.
He added the product is being made by Lithuanian contract manufacturing organisation (CMO) Biotechpharma. The facility is equipped with GE Healthcare’s Xcellerex single-use bioreactors up to the 2,000L scale.
Compared to second wave biosimilars such as versions of Remicade (infliximab) and Humira (adalimumab), less attention has been made of third wave biosimilars – versions of more complex mAbs or antibody fragment drugs coming off patent after 2020 – including Lucentis.
One such developer of a Lucentis biosimilar is Germany’s Formycon, which is hoping to bring its candidate FYB201 to market in the US in 2020.
In August 2016, Pfizer abandoned a Lucentis biosimilar programme it was undergoing with Pfenex.
In 2016, Lucentis brought in US sales of CHF 1.4bn ($1.4bn) for Roche, and $1.8bn for Novartis which commercialises the monoclonal antibody outside the US.