Originator brands vs generics

Comfort Maluleke, senior case manager at Campaigning for Cancer, offers guidance in understanding originator brands vs generics when navigating prostate cancer treatment.

You can listen to this article below, or by using your favourite podcast player at pod.link/oncologybuddies

Prostate cancer is a complex and challenging disease that places significant emotional and mental strain on patients. According to the 2019 National Cancer Registry, prostate cancer affects 1 in 15 men in SA. Navigating through the intricacies of the disease, understanding its progression, and selecting appropriate treatment options can be daunting.

As a senior case manager, I assist patients and doctors to gain access to the treatment they have agreed upon. I provide technical help in drafting letters of motivation to medical schemes to support treatment plans, prepare authorisation applications, and appeal declined treatment plans by medical aids.  

Daily I see patients grappling with prostate cancer diagnoses and the added burden of understanding the nuances of deciding between the treatment options suggested by their doctors. One of the questions that is often asked is: what is the difference between originator brands vs generics?

The difference between originator brands and generics

Originator brands are the first versions of a medicine developed and marketed by a pharmaceutical company. They undergo rigorous clinical trials to establish their efficacy and safety before receiving approval from regulatory bodies like The South African Health Product Regulatory Agency (SAHPRA).  

Each medication has a patent period during which only the developer can sell it. Once the patent expires, other manufacturers can produce and sell generic versions. If a manufacturer starts producing and selling it before, this is considered illegal and unethical.

Think of it like developing a chocolate cake recipe. The active ingredients are eggs, cocoa, milk, flour, sugar, and butter. Once your recipe’s patent expires, other bakers can use it. They will use the same ingredients and process but may choose different brands of sugar or cocoa and might use an electric mixer instead of folding the batter by hand.

In SA, we have very good laws and regulation that monitor and assess the quality, safety, and efficacy of generic medications seeing that they must meet similar standards of quality, safety, and efficacy as their originator (brand name) counterparts. 

Generic medication

However, generic medication may differ in terms of inactive ingredients, like using spray instead of butter to grease a pan, which can affect the medicine’s delivery and tolerability. Subtle variations in the ingredients and manufacturing processes can affect how the medication is absorbed by the patient’s body and how the patient responds to it.

It’s crucial for patients to monitor their reactions and communicate closely with healthcare providers if they experience any side effects or changes in their condition, no matter which treatment pathway they choose. 

Doctors might also mention a biosimilar; this is a generic version of the reference medication, that is derived from a biological source and not a chemical compound source.

Generics play a vital role in increasing access to essential medications as they are typically more affordable. 

However, affordability doesn’t trump the switching from an originator to a generic or biosimilar if it’s not as effective in treating the disease.

A simple scenario

Consider the case of a prostate cancer patient whose medical scheme or dispensing pharmacy switched his medication from an originator brand to a generic without the treating doctor’s knowledge. This is permitted under South African law unless the doctor specifies that switching isn’t desired on the prescription.

Since the patient’s medical scheme benefits only covered the generic version of the medication, the pharmacy dispensed the generic. The patient realised this, informed their doctor and the doctor pushed back against this decision by the medical scheme since switching from an originator brand to a generic can result in reduced effectiveness and affect the patient’s condition.

Patients have the right to be fully informed about their treatment options. This scenario highlights the importance of communication and the need for patients to be actively involved in treatment decisions. It also underscores the necessity for healthcare providers to advocate for their patients’ best interests and ensure that any changes in medication are well-justified and communicated. Patients should feel empowered to ask questions and seek clarity on why a particular medication is recommended.

Project ASK

Informed consent is a critical aspect of patient care. It ensures that patients are aware of their treatment options and the potential implications of each choice. When the waters turn murky and patients start feeling lost on their journey to navigate care, they can find refuge in the resources available, whether it be for further education, emotional support, or even financial support.

Project ASK can assist patients who are denied treatment or need additional support to navigate treatment options and authorisations. Organisations that are able to share the burden of a cancer diagnosis by improving patient access to innovative care also exist.

Understanding the difference between originator brands and generics is vital for prostate cancer patients. By being informed, monitoring their responses to medication, and knowing their rights, patients can make empowered decisions about their treatment. 

There is help, you just need to ASK.

Email Project ASK team – [email protected] or call 082 224 4224

Visit Access to Innovative Care Foundation aicf.org.za or Innovative Access Solutions ias.org.za