India gets low cost biosimilar of Remicade

[Fred]

India has got it's first biosimilar of Remicade (infliximab) called Infimab for the treatment of Psoriatic Arthritis and will be marketed at a very significant discount compared with Remicade.

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Ranbaxy Laboratories Limited (Ranbaxy), one of India’s largest pharmaceutical company, today announced the launch of InfimabTM (BOW015), the first *Remicade® (Infliximab) biosimilar in India. The product was launched at the Indian Rheumatology Association Conference (IRACON) in Chandigarh, in the presence of over a thousand rheumatologists and doctors from around the country.

InfimabTM, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialization of biosimilar monoclonal antibodies. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

InfimabTM marks Ranbaxy’s entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.

Talking about the significance of the newly launched InfimabTM, Rajeev Sibal, Vice President & Country Head-India Region, Ranbaxy, said, “InfimabTM offers a new opportunity in the management of conditions like rheumatoid arthritis. The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment.”

Rheumatoid arthritis is one of the most common chronic inflammatory diseases that cause disability. The literature estimates a prevalence of 0.5% to 0.75% in India. To manage the disease, Indian rheumatologists are using Infliximab to treat only a select set of patients because it is very expensive.

Dr. Arvind Chopra, Consultant Rheumatologist, Pune who was also the Principal Investigator of Clinical Trial conducted in India with InfimabTM (BOW015), stated, “There has been an inordinate interest among the medical fraternity in India regarding the launch of InfimabTM as it is an affordable therapeutic alternative to Infliximab with equivalent clinical effectiveness. The availability of the new drug has widened our options to treat several forms of arthritis. This will increase patient access and many more Indian patients will benefit from this biologic treatment. The drug will not only be able to stop progression of rheumatoid arthritis but effectively control several of its complications that include bone damage, deformities and osteoporosis. InfimabTM also has an excellent treatment potential to treat other crippling painful arthritis like ankylosing spondylitis and psoriatic arthritis”.

Amit Munshi, president and CEO of EPIRUS, stated, “We are delighted to partner with Ranbaxy to bring InfimabTM to India. InfimabTM represents an affordable solution for patients and may expand patient access to this important medicine”.

It is well established through studies that if a biologic treatment is started relatively early and patients adhere for the required duration as recommended by the physician, significant improvement in overall treatment outcome can be achieved. Along with the affordable pricing of InfimabTM, Ranbaxy has launched RAISE (Rheumatoid Ailment Infimab Support Endeavor) a patient support program for improving patient awareness and compliance on therapy. With a similar clinical safety and efficacy to Remicade®, a reduced cost of therapy, and patient support program, InfimabTM may encourage more patients to initiate and continue treatment, thus potentially improving the overall treatment outcome.

Source: ranbaxy.com

[jiml]

A question regarding biosimilars are their any restrictions on where they can be sold?
What I mean is are we likely to see price wars or pressure on the other drugs to reduce prices?

[Fred]

A question regarding biosimilars are their any restrictions on where they can be sold?
What I mean is are we likely to see price wars or pressure on the other drugs to reduce prices?

My understanding is that they can only be sold in the country they are approved for, they have to go through the same tests as the original to be deemed suitable under that countries regulations.

So in India both will be available but Infimab will be offered as a cheaper alternative, but as it's not approved for use say in the UK then it will still be Remicade that UK residents will get.

[jiml]

A question regarding biosimilars are their any restrictions on where they can be sold?
What I mean is are we likely to see price wars or pressure on the other drugs to reduce prices?

My understanding is that they can only be sold in the country they are approved for, they have to go through the same tests as the original to be deemed suitable under that countries regulations.

So in India both will be available but Infimab will be offered as a cheaper alternative, but as it's not approved for use say in the UK then it will still be Remicade that UK residents will get.

So will the biosimilar companies go for approval in other countries or will they stay where approval is easier

[Fred]

A question regarding biosimilars are their any restrictions on where they can be sold?
What I mean is are we likely to see price wars or pressure on the other drugs to reduce prices?

My understanding is that they can only be sold in the country they are approved for, they have to go through the same tests as the original to be deemed suitable under that countries regulations.

So in India both will be available but Infimab will be offered as a cheaper alternative, but as it's not approved for use say in the UK then it will still be Remicade that UK residents will get.

So will the biosimilar companies go for approval in other countries or will they stay where approval is easier

I would imagine they will go for where the market is, somewhere like India needs cheaper drugs but other countries would probably make it difficult for them.

Take here in France for example we are usually last to get new treatments as the French tend to hold back and wait and see, USA are usually first to give approval then Europe. But even if it gets approval by Europe the French will still conduct there own trials before going live.

They are now only just starting a program of testing for Fumaderm and it's not widely available, and won't be a for a while yet. I asked why they take so long and I got the impression it was let's see how what problems other countries get and let them do the donkey work, then we can do our own tests knowing what to look out for.

So I think it would be very difficult Infimab to get approval in France and if they did it would take a long time, whereas somewhere like Romania may be a better option for them.

[Caroline]

A question regarding biosimilars are their any restrictions on where they can be sold?
What I mean is are we likely to see price wars or pressure on the other drugs to reduce prices?

My understanding is that they can only be sold in the country they are approved for, they have to go through the same tests as the original to be deemed suitable under that countries regulations.

So in India both will be available but Infimab will be offered as a cheaper alternative, but as it's not approved for use say in the UK then it will still be Remicade that UK residents will get.

Yes that is correct.
E.g. Tecfidera is released in the Netherlands for MS. So now there is an obligation to use this only for MS. While cheaper variants are available.
Which is the same why Infimab will not be used in the UK, but instead Remicade is provided.
There is no reason for the industry to change that, as Remicade brings them more money, it is as easy as that.

[Fred]

Yes that is correct.

Thank you Caroline, I thought it was the case.

[mataribot]

Here in the US, biosimilars are expected to cost between 0 and 15 percent less than patent drug. I bet many people switch to newer biologics over the next few years to avoid the issues with the launch of the new drugs.