Rituximab, gets cheaper.

[Kwenda]

Rituximab goes off patent shortly and will soon be very much cheaper both for those with CLL and those with arthritis

..........................................

Intas launches Mabtas, a biosimilar version of Rituximab

Thursday, May 02, 2013, 12:15 Hrs [IST]

Intas Pharmaceuticals Ltd. has launched Mabtas, a biosimilar version of Rituximab competent in treating diseases characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells like Chronic Lymphocytic Leukaemia (CLL) and Rheumatoid Arthritis apart from Non-Hodgkin's Lymphoma (NHL) in India. With a view to make NHL treatment cost-effective, Mabtas is manufactured in the state of the art, Asia’s only EU GMP facility of Intas Biopharmaceuticals, Ahmedabad.

With the launch of this product, Intas now is the only company to have indigenously developed six biosimilars in the domestic market. The company is India's first and only biopharmaceutical companies to receive European Union - Good Manufacturing Practice (EU-GMP) certification for its microbial manufacturing facility and only company having product under-registration with EMA. Intas Biopharmaceuticals is already a leading manufacturer of Erythropoietin, G-CSF and peg G-CSF for India and have introduced world’s first biosimilar peg G-CSF. Mabtas marks the first monoclonal antibody (mAb) launch from Intas.

End

[Cllcanada Top Poster CURE Hero]

Good competition for Dr. Reddy's Reditux, a Rituxan biosimilar used in India since 2007...

Samsung Electronics and Teva Pharmaceutical both bailed out on biosimilar versions of rituximab (MabThera/Rituxan) last year amid uncertainty in regulation of copycat biologics in the U.S. and expensive development requirements that reduce the financial rewards of the drugs. Yet the $7 billion seller Roche, could find competition from others, as both Novartis's Sandoz unit and Boehringer Ingelheim have had Rituxan in their biosimilar plans.

Question is...who is going to test these new products...???

~chris

[MaudMarie in reply to Cllcanada]

And another question - Will these biosimilars have to go through the same approval process as the original drug before they can be widely used?

[Kwenda in reply to MaudMarie]

The wording on the news release states as above ' Intas Pharmaceuticals Ltd. has launched Mabtas, a biosimilar version of Rituximab '..

This is a biosimilar and thus I would have expected that the FDA would require the usual checks.

But note that this posting is now three years old...

[MaudMarie in reply to Kwenda]

Thanks Dick. I was just trying to work out if we need to be ready to support (or otherwise) a NICE approval of drugs like this.

[Cllcanada Top Poster CURE Hero]

Came across this list ... interesting that Intas isn't on it....

Rituxan / MabThera (rituximab)

Drug developers:

Amgen: Biosimilar in active development

BioXpress: Biosimilar in active development

Boehringer Ingelheim: BI695500 in Phase III development in U.S., EU, Brazil, Guatemala, Russia, Norway, Ukraine, Argentina, Peru, New Zealand. U.S. study recruiting participants as of April 17, according to ClinicalTrials.gov (NCT01682512)

Celltrion and Hospira: Conducting Phase I trial in South Korea of CT-P10 for RA and another Phase I trial for lymphoma.

Dr. Reddy’s Laboratory: Reditux® marketed in Bolivia, Chile, India, and Peru

iBio: Announces October 5, 2011, that it produces rituximab in nontransgenic green plants. More recent announcements, however, focus on the company’s technologies for developing biosimilar and proprietary drugs. On April 26, 2012, announces results of ongoing tests showing that its immunomodulator molecule lichenase (LicKM) enhances vaccine antigens when produced as fusions to LicKM. iBio said it will offer commercial collaborations and product licenses to the immunomodulator, dubbed iBioModulator™, which last month was awarded U.S. Patent No. 8,404,252. The iBioModulator has been shown in animal models to increase the strength and extend the duration of immune response to a vaccine antigen.

Merck: MK8808 in Phase I development for EU, with trial in Belarus

Pfizer: PF-05280586 set this year to complete a Phase II trial launched March 2012 comparing the biosimilar to Rituxan/MabThera. “This year, we expect data,” Mikael Dolsten, president of Pfizer’s Worldwide Research & Development unit, said on the Q4 2012 earnings conference call January 29.

Probiomed: Kikuzubam® marketed in Bolivia, Chile, Mexico, and Peru

Roche: CEO Severin Schwan was quoted in March as pushing back his company’s anticipated launch of a rituximab biosimilar beyond the 2016 date he had earlier cited in The Wall Street Journal, until the end of this decade.

Sandoz: GP2013 in Phase I/II trial for rheumatoid arthritis and non-Hodgkin’s lymphoma, and a Phase III trial for advanced folicular lymphoma. As of last year, the biosimilar was in Phase II trials in Argentina, Austria, Brazil, France, Germany, India, Italy, Spain, and Turkey.

Stada Arzneimittel: Joined with Gedeon Richter in announcing plans August 2011 to collaborate on biosimilars for rituximab and trastuzumab. Stada receives nonexclusive rights to sell Richter-produced rituximab in Europe and the Commonwealth of Independent States, excluding Russia. In addition to an undisclosed payment to Richter, Stada also agrees to pay Richter based on progress of the development of rituximab to a “low double-digit million Euros”

Recently discontinued efforts:

Teva and Lonza: End planned 544-patient, Phase III clinical trial of TLO11, saying they wanted input from regulators on designing the trial program (October 2012). On April 5, Lonza issues statement denying news reports that it will end its biosimilar joint venture with Teva

Samsung Biologics: Venture between Samsung and Quintiles halts development of SAIT101, in October 2012, reportedly due to uncertainty over biosimilar regulation in the U.S.

Nature and indication: Chimeric mouse-human monoclonal antibody, for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis

2012 sales: $7.190 billion (CHF 6.707 billion) (Roche)5

Patent status: Patents set to expire later this year in EU, and 2018 in U.S.

Source

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