Question 1

What is a generic version of a specialty medicine?

Accepted Answer

A generic specialty medicine is chemically identical to a reference specialty medicine, but manufactured and distributed after the original brand's patent has expired. The medicines are produced and sold by other manufacturers at a significantly lower cost. If small molecule specialty drugs (such as Imatinib, Sorafenib, Tenofovir, Entecavir) are shown to be bioequivalent, then their effects are the same as the originator, and can be routinely used in clinical practice.

Question 2

What is a biosimilar? Is it the same as a generic medicine?

Accepted Answer

No, biosimilars and generics are not the same. Large, complex protein molecules such as monoclonal antibodies, targeted immunotherapy drugs and growth factors used in biologics cannot be the same as the originator, as they are derived from living cells. Individual biologic is unique even among biological systems. A biosimilar is a biologic that is highly similar in terms of quality, safety and efficacy to a previously approved biologic (the reference product), demonstrated through rigorous comparisons. Examples of biologics with approved biosimilars include Trastuzumab biosimilar (for HER2+ cancer), Rituximab biosimilar (for Lymphoma), Bevacizumab biosimilar (for cancer).

Question 3

Are generic specialty medicines and biosimilars as effective as the original branded versions?

Accepted Answer

Small molecule generics will demonstrate the same therapeutic benefit as the originator once approved, for example a generic Imatinib should deliver the same clinical benefit as Gleevec/Glivec at a lower cost. The safety and efficacy of biosimilars must be proven through extensive comparisons to the reference biologic via extensive clinical testing before approval. However, well-established biosimilars from reputable manufacturers are often therapeutically interchangeable for most indications. Changes from the originator biologic to a biosimilar must always be prescribed by and discussed with your oncologist or specialist, who will authorize and monitor the change.

Question 4

Which specialty disease categories have good generic or biosimilar options available?

Accepted Answer

- Oncology (TKIs), generics are widely available in India, examples are Imatinib, Gefitinib, Erlotinib, Sorafenib, Sunitinib, Dasatinib. - Oncology (biologics/biosimilars), examples are the approved biosimilars of Trastuzumab, Rituximab, Bevacizumab, Cetuximab. - HIV/ART, generics are easily available and at a very affordable price, examples are Tenofovir, Lamivudine, Efavirenz, Dolutegravir combinations. - Hepatitis B & C: Entecavir, Tenofovir (HBV); Sofosbuvir, Daclatasvir, Ledipasvir (HCV); with India a leader in the production of generics of HCV treatments. - Transplant, although preference can be for brand in some cases, generic Tacrolimus and Mycophenolate are available. - Rheumatology / Autoimmune, generics are already readily available, examples being Methotrexate and Hydroxychloroquine.

Question 5

My doctor prescribed a specific brand. Can I switch to a generic or biosimilar version?

Accepted Answer

This can only be done with the direct instruction of your physician. When prescribing for oncology or transplant medications in particular, there may be brand preference from your physician, more related to a clinical need than solely a commercial one. You should never switch the brand of any specialty medication or biologic yourself for the first time without your physician's specific instruction and confirmation. We supply whatever your physician prescribes, or whatever you are authorized to have as an alternative.

Question 6

Are Indian-manufactured generic specialty medicines safe and of acceptable quality?

Accepted Answer

India has manufactured and supplied the largest amount of anti-retrovirals in the world and a very large proportion of generic TKIs and generic HCV treatments. It is in the top world-class producers of generic specialty drugs. They are approved and regulated to the WHO-GMP standard in western countries like the USA, UK and EU, however quality can vary from one manufacturer to another. Magicine Pharma aims to supply only those generic specialty drugs manufactured by producers with appropriate regulatory credentials, rather than going for the lowest-cost product on the market.