Tiny Mabion Races Big Pharma To EU Rituximab Market
Executive Summary
Poland’s biotech Mabion is racing to the European biosimilar market with a biosimilar rituximab, but is up against multinational biosimilar companies like Sandoz and South Korea’s Celltrion, and will likely need a strong commercialization partner outside its home market.
Poland’s fledgling biotech company, Mabion SA, believes it is among the leaders in the race to develop a biosimilar version of Roche's monoclonal antibody, MabThera/Rituxan (rituximab), for Europe, but it needs to finalize a tie-up with a marketing partner or partners fast, as they will need time to prepare to compete against biosimilar heavyweights that are also developing versions of the blockbuster TNF-inhibitor.
Mabion expects to administer the last doses of its biosimilar rituximab, MabionCD20, in pivotal clinical studies this summer – in June 2016 in a rheumatoid arthritis study, and in August 2016 for a study in lymphoma - with an EU approval submission expected to be filed in early 2017.
That’s in the vanguard of companies vying to introduce biosimilar rituximab in major EU markets, since patent protection expired on the innovator product several years ago. Currently Mabion’s version could be second to the EU market, behind that manufactured by Novartis AG’s generics and biosimilars division Sandoz. The Swiss firm announced May 24 the acceptance of its submission to the European Medicines Agency of its biosimilar version of rituximab (Also see "Sandoz Extrapolates Biosimilar Rituximab Data For EU Filing" - Scrip, 24 May, 2016.). Analysts at ING expect MabionCD20 to be marketed in the EU in the first quarter of 2018 and in the US in the first quarter of 2019.
However, there is much activity in the sector and other companies may come forward to fight over a market in Europe that could be worth up to CHF1.26bn ($1.27bn) annually - estimated by applying a 30% reduction to Roche’s 2015 European sales of MabThera of CHF1.8bn.
30% is the approximate pricing discount to the innovative product's price given by biosimilars when they are first launched in Europe. However, the use of tenders by some healthcare providers has driven down the cost of biosimilars drastically in some European countries. In Norway, for example, Celltrion Inc.’s biosimilar version of infliximab, Remsima, won a hospital supply tender with a 69% price reduction compared with the innovator product several years ago, only to be replaced a year later by Hospira Inc./Pfizer Inc.’s Inflectra, that gave a steeper price drop (Also see "Ten Years On, Access To Biosimilars Still Patchy in EU" - Scrip, 3 May, 2016.).
Globally, the market opportunity for biosimilar rituximab is large, with Roche’s worldwide sales of MabThera/Rituxan totaling $7bn in 2015. However, the big pharma company is already competing with a number of other versions of rituximab that have been launched in countries that have different regulatory requirements to those in Europe.
These include Biocad’s AcellBia (BCD-020), that has been launched in Russia, Pakistan, Vietnam and other emerging countries, and the St. Petersburg-based company reports that its version was evaluated using clinical studies that comply EMA guidelines. The Spanish company MAbxience’s version of rituximab has been launched in Latin America (Also see " Taking On The Big Guns: Life As A Boutique Biosimilar Developer " - Scrip, 22 Oct, 2015.). There are also a number of rituximab versions available in India, including Dr. Reddy's Laboratories Ltd.’s Reditux, Intas Pharmaceuticals Ltd.’s Mabtas and Hetero Drugs Ltd.’s Maball.
Status Of Leading Companies Developing Biosimilar Rituximab
|
Company |
Designation |
Status |
|
Sandoz |
GP2013 |
filing accepted By EMA |
|
Mabion |
MabionCD20 |
Phase III |
|
Shanghai Henlius Biotech Co. Ltd. |
HLX01 |
Phase III |
|
Pfizer |
PF-05280586 |
Phase III |
|
IBC Generium |
Deplera (GNR-006) |
cleared for clinical trials |
|
Allergan PLC/Amgen |
ABP 798 |
preclinical |
|
RGB-03 |
in development, stage unknown |
|
|
3S Bio |
- |
in develoment, stage unknown |
Source: Citeline’s Pharmaprojects, Sagient’s BiomedTracker and companies.
Advanced Manufacturing
Mabion is well advanced in its planning for the launch of rituximab. The Polish company has built its own manufacturing facilities in Konstantynow Lodzki in the center of Poland, near the city of Lodz, and intends to market the product in Poland, but is seeking partners to commercialize it in other countries. Mabion is in advanced talks with several potential partners, and these potential partners include both global players and small biotech companies, a company spokeswoman told Scrip.
The Kutno, Poland-based company may have advantages over larger competitors because it is nimble and able to make decisions quickly, the spokeswoman noted. It has also taken prudent path to product development, seeking scientific advice from the European Medicines Agency (EMA).
Mabion is an unusual company in that it was set up by four pharmaceutical companies in Poland, that came together to create the new biotech company. Its setup was led by current President and CEO Maciej Wieczorek, who also founded and is currently president of the oncology drug marketer Celon Pharma SA, one of the four companies. Celon was joined by Polfarmex, a marketer of prescription drugs in the country, the vaccine manufacturer IBSS Biomed, and Genexo, which markets pharmaceuticals and medical devices. Mabion floated on the Warsaw Stock Exchange in 2010.
Funding from its four founding companies and the EU has helped support the building of the up-to-date biosimilars manufacturing facility that claims to have some of the most up-to-date manufacturing equipment found anywhere, including a robotic sterile product filing line.
Mabion is also evaluating the development of biosimilars to Herceptin (MabionHER2), Erbitux (MabionEGFR) and Avastin (MabionVEGF).