ACCESS to affordable medicine is crucial for any patient, particularly those facing life threatening conditions.
As a result, members of the breast cancer and chronic myeloid leukaemia community have welcomed the manufacture of generic oncology drugs in Malaysia.
Earlier in the year, Duopharma HAPI Sdn Bhd, successfully manufactured and commercialised its first generic product which is prescribed for breast cancer treatment.
The adoption of drugs with similar bio-equivalence to innovator therapies can improve outcomes in oncology settings.
The RM50 million HAPI plant is equipped to produce a wide portfolio of cancer medicines to treat breast, lung, colorectal, cervical and blood cancer among others.
The facility is also fully capable of producing medicines to treat hormonal imbalances and highly potent medicines for cardiovascular, central nervous system and musculoskeletal diseases. These products may also be manufactured for export markets.
Oncologist and director of Beacon Hospital, Datuk Dr Mohamed Ibrahim, says over the last decade, the quantum of generic drugs used in oncology has increased by 40-50 per cent in the private sector and it is significantly higher in government hospitals.
Universiti Sains Malaysia, department of medicine, Associate Professor, Dr Azlan Husin, says the majority of patients are acceptable to the idea of being treated with generic medicines. In the public sector, most oncology drugs are generics, he adds.
Both Dr Azlan and Dr Mohamed agree that manufacturers of generics should help promote the adoption of their generic therapies by conducting more clinical trials or bioequivalence studies to ensure the efficacy and safety of generic drugs.
"I would like generic companies to work with hospitals, teaching hospitals and research institutes to conduct trials on certain clinical indications. Alternatively, generic drug companies could also sponsor these drugs so hospitals and research institutes can undertake studies on their own," says Dr Mohamed.
Dr Azlan adds that generic manufacturing companies should embark on robust R&D initiatives to ensure that the generic drug compound is the same or almost equal to originators. They should also invest in local trials.
Breast Cancer Welfare Association Malaysia president, Ranjit Kaur, says availability and access to quality generics would greatly assist patients and caregivers in promoting better treatment outcomes.
"Affordability and access issues are especially prevalent amongst the financially challenged and there is evidence that out-of-pocket costs for prescription drugs to treat chronic diseases not only impose a financial burden but result in reduction in medication adherence, leading to worsening health outcomes."
The availability of proven and competitively priced drugs will significantly benefit less financially secure communities.
The escalating cost of medication has been a challenge for the government to provide accessibility of effective medication to patients she adds.
Duopharma Biotech Berhad group managing director, Leonard Ariff Abdul Shatar, says the objective behind the establishment of the HAPI plant in Malaysia, is to offer medication to address the lack of alternatives, while delivering equitable and affordable access to prescription medications.
The plant will also provide some level of self-sufficiency to the country in terms of specific oncology medications.
The HAPI facility is a Good Manufacturing Practice (GMP) certified plant by the Malaysian National Pharmaceutical Regulatory Agency (NPRA). This ensures that production and quality control consistently meet the highest standards.
"Duopharma Biotech Group is embracing innovation and technology to serve patients who need specific and targeted therapies that can be produced by our new state-of-the-art HAPI plant," says Leonard.
Duopharma Biotech will also actively seek collaborations with pharmaceutical companies across the globe to import high-end technologies and ventures that facilitate technology transfer to enable it to locally manufacture high-value drugs.
"We are widening our product portfolio in offering not just oncology medicines but also psychotropic drugs, which is an emerging market in Malaysia," adds Leonard.