Dr Schreitmueller
BIG pharmaceutical companies have often been accused of “extending”
their drug patents for as long as possible, depriving many patients of
cheaper generic versions of drugs that could potentially save their
lives or improve their conditions.
Called evergreening, NGOs had
said these companies tend to “extend” drug patent just before the
20-year expiry period by making only a slight modification.
Dr Thomas Schreitmueller, Regulatory Policy Head at Roche Global, argues this is not necessarily the case. While
this may be the contention for generic drugs, it is not for biological
products, says Dr Schreitmueller who is based in Basel, Switzerland,
citing the difference between trastuzumab and trastuzumab emtansine. While Trastuzumab can slow or stop the growth of breast cancer,
the newer trastuzumab emtansine can kill breast cancer cells, he says. With
trastuzumab, patients will still have to get a separate chemotherapy to
kill the cancer cells but with the newer trastuzumab emtansine,
patients do not need to go for a separate chemotherapy, Dr
Schreitmueller explains.
In this case, he tells The Star in an
interview, “You clearly change the purpose of the molecule. And this is
different from ever-greening.”
Dr Schreitmueller points to another
example of innovation – the first generation Interferon alfa-2a for
treating Hepatitis C, which is made of pure protein, but years later,
the protein was modified by pegylation (chemical modification to the
protein). This changed the pharmacokinetic (bodily absorption, distribution, metabolism, and excretion of drugs) profile of the product.
With
the pegylation immunogenicity in patients being lower, the dosing
frequency could be lowered, he says, adding that the “new” product also
shows a higher efficacy compared with the former version.
According
to Dr Schreitmueller, an originator product is more expensive than a
biosimilar because when developing the use for the antibody for treating
each of the diseases or condition (indications), the originator company
will have to carry out clinical studies for each of the indications
while this is not required for biosimilar products.
A biosimilar
company may extrapolate positive data from one clinical similarity
assessment in one indication to all other indications of the originator
product, besides the needed demonstration of analytical and preclinical
similarities, he says.
In developing a new drug for 10
indications, a pharmaceutical company may have to do more than 10
clinical studies while a manufacturer of a biosimilar product (a
biologic medical product that is almost identical copy of an original)
may have to do only two, he says.
There is also a low risk of
failing to demonstrate safety and efficacy for the biosimilar product as
this was already demonstrated by the originator product, he says.
Dr
Schreitmueller also points out that a high level of similarity between a
biosimilar and the originator product was important to mitigate the
risk of interchangeability (switching), particularly with cancer
products.
“You cannot do with biologics what you may do with
synthetic drugs that are not immunogenic because if the patient has
developed an immune response to the biosimilar after a switch and thus,
does not work anymore, this immune response may also neutralise the
originator product and it also will not work anymore for the patient.
“So there is no point switching back to the originator product,” he says.
However,
he says for rheumatoid arthritis, patients may switch to other
treatments if one fails because there are many other options available.
In
view of such delicate situation with biologics and biosimilars, Dr
Schreitmueller urges the Malaysian authorities to be more transparent in
its regulatory decision making by coming up with an objective
evaluation report and not leave the education of the products to
companies or other stakeholders.
This is crucial for physicians and patients to make unbiased treatment decisions, he stresses.
“In Europe, whenever the European Medicine Agency (EMA) approved a pharmaceutical product, it will publish an evaluation report.
“In
the report, the physicians, patients and other stakeholders are able to
find information such as the results of the clinical studies,
preclinical and analytical studies with conclusion from EMA as well as
the reason why a certain product is approved.”
Pharma co-vigilant (monitoring of side-effects) is also important after a product is released into the market, he adds.
Asked
how pharmaceutical companies can address the issue of high drug cost
that is inaccessible to many patients and and put a burden on health
care systems, Dr Schreitmueller says in cases without competition, it
would be useful to identify specific patients where the drugs would work
with a high likelihood, such as through tumour gene analysis.
“Currently, we may have a drug, such as for lung cancer approved, but it may not work on all lung cancer patients.
“If
we are able to treat only a specifically identified population, a sub
group, this will make the system more efficient and achieve cost
effectiveness,” he says.
In cases where we have competition such
as biosimilars, the Government buying several products from the same
molecule instead of allowing only single win contract, enables and
maintains competition.
On NGOs arguing that most of the discovered
compounds were researched in public universities – thus paid by tax
payers and should not cause drugs developed to be too expensive – Dr
Schreitmueller points out that these institutions are not necessarily
involved in the costly development efforts leading to a safe and
effective product, which are usually done by the pharmaceutical
companies. - The Star
