[Ip-health] Health Policy Watch: Biosimilar Breast Cancer Drug Gets WHO Seal Of Approval – Agency Aims To Increase Worldwide Access To Life-Saving Treatment

Thiru Balasubramaniam thiru at keionline.org
Thu Dec 19 04:22:06 PST 2019


Biosimilar Breast Cancer Drug Gets WHO Seal Of Approval – Agency Aims To
Increase Worldwide Access To Life-Saving Treatment

18/12/2019 by Elaine Ruth Fletcher

The World Health Organization (WHO) has given its quality seal of approval
to a biologically similar formulation of the breast cancer drug  –
trastuzumab – in a move the agency says could help make the costly,
life-saving treatment more affordable and available to women globally.

Breast cancer is the most common form of cancer in women. Some 2.1 million
women contracted breast cancer in 2018. 630,000 of them died from the
disease, many because of late diagnosis and lack of access to affordable
treatment, WHO said in a press release announcing the move.

Trastuzumab – a monoclonal antibody – was included in the WHO Essential
Medicines List in 2015 as an essential treatment for the estimated 20% of
breast cancer tumors that test positive for the protein human epidermal
growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
In such tumors, the drug has shown high efficacy in curing early stage
breast cancer and in some cases more advanced forms of the disease, WHO

Trastuzumab, which was originally produced under the brand name Herceptin®
by Roche Pharmaceuticals, is among a number of biotherapeutics, or
pharmaceutical products, derived from biological and living sources, which
have become increasingly important in cancer treatment. “Biosimilar”
formulations of biological health products are the equivalent of generic
formulations of synthetic drugs.

Cancer patient received a drug infusion

The newly pre-qualified product is produced by the Dutch-based firm Samsung
Bioepis; it was the first is the first trastuzumab product to be assessed
by WHO and found comparable to the originator product in terms of efficacy,
safety and quality, the global health agency said.

The WHO Prequalification process is a seal of good quality that makes a
drug company’s product eligible for bulk procurement by United Nations
agencies. But in the case of drugs for cancer and other non-communicable
diseases, there are almost no UN-based donor programmes for procurement and
supply to low-income countries.

Even so, the WHO label will signal to national governments that the product
is quality-approved by WHO. Such a signal can eventually help pave the way
for more bulk purchases of  cheaper, but quality-approved biosimilar cancer
drugs by national health systems, thereby reducing prices, said a WHO
scientist in an interview with Health Policy Watch.

“Historically, the WHO Prequalifiation process was used to pave the way for
procurement of products for HIV, TB and malaria [by donors and UN
agencies]. Then, it was expanded to some reproductive health drugs and to
diagnostic devices, and then to drugs for other neglected diseases.  Now,
cancer has become part of the process.  Although we don’t have a big
procurement of cancer drugs from a UN agency, this signals that cancer
treatment is an integral part of Universal Health Coverage, and should be
part of a national benefits package,” the scientist said.

Integration of such drugs into the WHO Prequalification process could help
drive down costs of treatment by about 60-70% of the prevailing prices:
“but lets see how the market reacts,” the scientist said. Currently, costs
be US $20,000 or higher for a six-month course of treatment with the brand
name product, according to WHO. In the USA costs of around $US 40,000, have
been cited,as the baseline cost for the treatment.

“WHO prequalification of biosimilar trastuzumab is good news for women
everywhere,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General in
the press release. “Women in many cultures suffer from gender disparity
when it comes to accessing health services. In poor countries, there is the
added burden of a lack of access to treatment for many, and the high cost
of medicines. Effective, affordable breast cancer treatment should be a
right for all women, not the privilege of a few.”

Biotherapeutic medicines, which are produced from biological sources such
as cells rather than synthesized chemicals, are important treatments for
some cancers and other non-communicable diseases. Like generic medicines,
biosimilars can be much less expensive versions of innovator
biotherapeutics while keeping the same effectiveness. They are usually
manufactured by other companies once the patent on the original product has

WHO’s International Agency for Research on Cancer estimates that by 2040
the number of diagnosed breast cancers will reach 3.1 million, with the
greatest increase in low- and middle-income countries.

A recent study of breast cancer in sub-Saharan Africa found that of 1325
women surveyed in three countries, cancer treatment had not been initiated
within one year of diagnosis for 227 (17%) women and for 185 (14%) women
with stage I-III disease. Self-reported treatment barriers confirmed
treatment costs as a major contributor to not receiving treatment.

“We need to act now and try to avoid more preventable deaths,” said
Mariângela Simão, WHO Assistant Director General for Medicines and Health
Products. “The availability of biosimilars has decreased prices, making
even innovative treatments more affordable and hopefully available to more

James Love of Knowledge Ecology International, which has advocated for
reducing cancer drug prices as an important element of increasing drug
access, welcomed the WHO move but said that more needed to be done to fund
the WHO Prequalification process more fully so that it could conduct more
such reviews, and more rapidly.

“The PreQual process has always been very important to patients,
particularly those living in countries with limited capacity to provide
safety and efficacy regulation,” Love said in a statement to Health Policy
Watch. “The limitations on this process have largely been financial,
finding donors or other ways to pay for the necessary reviews. It’s a stain
on the WHO and its members that the agency has never been able to marshal
the resources that are needed to expand the program into the many areas
where it is needed, and certainly drugs for cancer and biologic drugs are
among those areas where PQ is really needed.  The Samsung trastuzmab
decision is a welcome step, and one hopes that someday the WHO will have
the resources to do what is needed.”

However reducing the price of cancer drugs such as trastuzumab will not,
alone, ensure that women get cancer treatment in low or even middle income
countries, WHO officials also stress. Use of the drug firstly requires a
well functioning health system that can provide early diagnosis of cancer
tumors, followed by appropriate surgery, chemotherapy and/or radiation
treatment, as preconditions for optimal use of biological drug therapies.

“It’s not a test and treat pill,” underlined the WHO scientist in the
Health Policy Watch interview. “Its part of a combined regimen, and fairly
complex. These are not easy drugs to delvier, and the largest gains are
generally for women with early diagnosed breast cancer of HER2+.   Still,
this signals how WHO is trying to project cancer drugs as something for
which we should increase the uptake.

Gene-based therapies such as CAR-T are among the other new biologic
“specialty treatments” that have been developed to treat other rare forms
of cancer, and currently they come with even higher price tags attached.
Examples of other biotherapeutics products, include therapeutic vaccines,
blood, blood components, cells, gene therapies, tissues and other
materials. They are used to treat chronic diseases such as diabetes,
Crohn’s disease and other autoimmune conditions, including lupus, and
various forms of rheumatoid arthritis.

WHO Prequalification is a service provided by the agency to assess the
quality, safety and efficacy of products that address global public health
priorities. Products that receive WHO’s seal, are then listed on the
Prequalification web site as eligible for procurement, giving purchasing
agencies a range of quality-assured diagnostics, medicines and vaccines
from which to choose. Every year, billions of dollars’ worth of medicines
and other health products are purchased by international procurement
agencies for distribution in low-income countries, based on WHO
recommendations. Many low-income countries also use WHO’s lists of
prequalified products to guide their selection of medicines, vaccines and
technologies for national procurement.

In July 2018, WHO launched a pilot project expanding the scope of
prequalification to two biotherapeutic medicines, including rituximab used
to treat certain leukemias and lymphomas, along with trastuzumab, as a step
towards making some of the most expensive treatments for cancer more widely
available in low- and middle-income countries. About six other companies
have begun producting trastuzumab over the past five years, driving down
prices of the original product, but the Dutch product is the first to be
prequalified as part of the pilot.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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