INTRODUCTION:

A significant portion of healthcare expenditures is directed towards medications. As advancements in healthcare continue, this expenditure is anticipated to rise considerably. This increase is driven by demographic shifts and improvements in diagnostic capabilities, leading to more frequent identification of conditions such as hypertension and diabetes.¹

Generic Drug:

A generic drug is a copy of a brand-name drug. It has the same form, strength, way of being taken, quality, how it works, and use. When the original drug's patent ends, other companies can make and sell the generic version. This makes the medicine cheaper and just as safe and effective.

· Stringent quality control

· Low manufacturing cost

· Low marketing investment

· Low retailer margin

Branded drug:

A branded drug is the original product developed by a pharmaceutical company. It is a new medicine created and sold by the company, which has the exclusive right to make and sell it for a certain period because of a patent. This patent prevents other companies from making and selling copies of the drug.

· Stringent quality control

· High manufacturing cost

· High marketing investment

· High retailer margin

A drug has two names: a generic name and a brand name. The brand name helps it stand out in the market. Branded medicine is the original drug made by a company, which has the exclusive right to sell it for a certain period due to a patent. After the patent ends, other companies can make a copy of the drug, called a generic, which is usually cheaper.^2,3 Generic drugs have the same active ingredient in the same amount as the brand-name medicine. Both branded and generic medicines meet international standards.

Generics might have different brand names and can look or taste different because they use different fillers and ingredients. They can be sold under their own names or as "branded generics" to be marketed like the original branded drugs.⁴ The non-proprietary name is the official name for the main ingredient in a medicine and is used worldwide.⁵ The switch from brand-name drugs to generics depends on how quickly generics can replace the branded medications.⁶ Public policies can influence this switch. Policies that encourage the use of generics can make the change happen faster, reducing healthcare costs because generics are cheaper.⁷ Generic drugs are made to work just like brand-name drugs. They are produced in the same types of factories and follow strict rules to ensure they are safe and high-quality. Although there might be minor differences in inactive ingredients, these do not affect how well the drug works. Overall, generics are just as effective and reliable as brand-name drugs.

Different between branded and generic:

Generic drugs:

A generic drug must have the same active ingredients as the original brand-name drug. The U.S. Food and Drug Administration (USFDA) states that the pharmacokinetic and pharmacodynamic qualities of generic medications are the same as those of their brand-name equivalents, or they fall within an approved bioequivalent range. The USFDA views generic medications as being equivalent to name-brand medications in terms of dosage, potency, mode of administration, safety, effectiveness, and intended purpose. A medication that is manufactured and sold without a patent is known as a generic medication. The active ingredient in the generic medication may not be covered by the patent, but the formulation may still be. When a generic formulation is shown to not infringe upon the innovator formulas or the patent protections granted to the original creator have expired, generic products become available. Competitive pricing for both the original brand-name product and its generic versions frequently results in significant price reductions when generic products are made available. It takes different amounts of time for a generic medication to become available.⁸

Generic drugs are medications created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. Here are some key points about generic drugs:

· How Generic Drugs are Made:

Approval Process: Organizations such as the FDA are required to approve generic drugs. They must demonstrate that, in order to be considered bioequivalent, they release the same quantity of active chemicals into the bloodstream as the name-brand equivalent.

Cost: Typically, generic medications are far less expensive than name-brand ones. This is a result of the generic manufacturer not needing to carry out the costly clinical trials again. Multiple companies can produce the same generic, increasing competition and lowering prices.

Appearance: Generics might look different (in color, shape, or packaging) from the brand-name versions but have the same active ingredients and work the same way.

Labelling: Generic drugs must have similar labels to brand-name drugs, including information on usage and side effects.

Patent: Generics become available after the patent on the brand-name drug expires. This usually occurs several years after the original drug is released.

Effectiveness: Generics are required to show that they are bioequivalent to the brand-name drug, meaning they work in the same way and provide the same clinical benefit.

Availability: Not all brand-name drugs have generics available immediately after patent expiration due to various market factors, including exclusivity agreements and manufac-turing issues.

Insurance Coverage: Many health insurance plans encourage the use of generic drugs by offering lower co-payments compared to brand-name drugs.

Active Ingredients: The active ingredient in a generic drug is the same as in the brand-name drug.

Inactive Ingredients: These may differ between generic and brand-name drugs, but they do not affect the therapeutic action of the drug.

Manufacturing Process: Producers of generic drugs are required to show that their methods of production adhere to the same criteria as those used by producers of name-brand drugs.

Approved Generic Drug Procedure:

Patent Expiration: Before a generic version of a brand-name medication is authorized, its patent must expire.

The FDA requires generic medication producers to submit an ANDA, or abbreviated new drug application, along with proof of manufacturing quality and bioequivalency.

Review and Approval: The FDA examines the ANDA to make sure the generic medication is high-quality, safe, and effective.

Security and Efficiency:

Monitoring: To guarantee continued safety and efficacy, the FDA keeps a close eye on reports of adverse events for both name-brand and generic medications.

Safety: Because generic medications are subject to stringent testing and manufacturing requirements, they are equally safe as name-brand medications.

Branded drug:

Branded drugs are medications sold under a trademarked brand name by specific pharmaceutical companies. These are also known as brand-name drugs. According to the IQVIA Institute for Human Data Science (2019), people often pay a significant amount for these brand-name medicines. However, high prices alone do not indicate whether these medicines are overpriced; we must evaluate if they are worth the cost.

There are varying opinions on the pricing of these drugs and their value. Some believe that drug prices are determined without sufficient consideration of their actual value, arguing that brand-name drugs are excessively expensive for the benefits they provide. Critics claim that pharmaceutical companies wield too much power, enabling them to set high prices even for medicines that offer minimal additional benefits.⁹

How branded drugs are made:

Active Ingredient:

The active ingredient is the chemical substance that produces the drug's therapeutic effect. Brand-name medications may contain one or more active ingredients.

Formulations and Dosing:

Brand-name medications can be available in different formulations (such as tablets, injections, creams) and varying dosing strengths, depending on the treatment requirements.

Development Process:

Discovery and Development:

· Research: Involves identifying potential compounds and understanding their mechanisms of action.

· Preclinical Studies: Test the drug in laboratories and animal models to assess safety and effectiveness.

· Clinical Trials: Conducted in four phases to test the drug in humans, each with increasing numbers of participants.

Approval:

· Regulatory Submission: A comprehensive dossier including preclinical and clinical data is submitted to regulatory agencies.

· Review and Approval: Agencies like the FDA or EMA review the data to ensure the drug’s safety, efficacy, and quality before granting approval.

Exclusivity Period:

· Duration: Typically lasts about 20 years from the filing date, but the effective market exclusivity is often shorter due to the time taken for development and approval.

· Market Exclusivity: Some types of exclusivities can extend the period during which no generic versions are allowed.

Pricing and Market Access:

· Cost-Based Pricing: Prices reflect the cost of research, development, and production.

· Value-Based Pricing: Prices are set based on the perceived value and benefits of the drug compared to existing treatments.

Clinical trial on branded drugs:

Clinical trials are crucial for the development and approval of branded medications, as they validate their safety, effectiveness, and overall advantage for patients. The process involves several distinct phases, each with specific objectives and methodologies. Here is an outline of the clinical trial process for branded drugs:

Phases of clinical trial:

1. Pre-clinical Research:

· Goal: Assess the drug's safety and biological activity through lab and animal studies.

· Result: Determine if the drug is safe enough for human testing.¹⁰

2. Phase 1: Safety and Dosage:

· Participants: 20-100 healthy volunteers or patients.

· Goal: Test the drug's safety, tolerability, pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted), and pharmacodynamics (the drug's effects on the body).

· Result: Identify the safest dosage range and observe any side effects.¹¹

3. Phase 2: Efficacy and Side Effects:

· Participants: Several hundred patients with the condition the drug aims to treat.

· Goal: Evaluate the drug's effectiveness and further assess its safety.

· Result: Determine the optimal dose and gather preliminary data on effectiveness and side effects.¹²

4. Phase 3: Confirmation and Comparison:

· Participants: Several hundred to several thousand patients.

· Goal: Confirm the drug's efficacy, monitor side effects, compare it to standard treatments, and collect information for safe use.

· Result: Provide a comprehensive understanding of the drug's benefits and risks, leading to data submission for regulatory approval.

5. Phase 4: Post-Marketing Surveillance:

· Participants: Patients using the drug after it has been approved and marketed.

· Goal: Monitor the drug's long-term effectiveness and impact, identify rare or long-term side effects, and ensure ongoing safety.

· Result: Ensure the drug remains safe and effective in the general population.¹³

Approval by Regulation:

Once every stage of the clinical study is finished, the data is sent for evaluation to regulatory organisations (such the EMA in Europe or the FDA in the US). To decide if a medicine is safe and effective for the intended purpose, these bodies assess the available evidence. Once authorised, the medication can be sold and given to patients.

Obstacles and Things to Think About Ethical Considerations: obtaining informed consent, safeguarding patient privacy, and upholding moral principles all during the experiment. Placebo Effect: To control for the placebo effect and guarantee objective results, use double-blind, placebo-controlled study designs. Patient Recruitment: To guarantee that the findings are generalisable, a sufficient and varied number of participants must be recruited. Adverse Events: Quickly keeping an eye on and handling unfavourable occurrences to safeguard participants' security.

Case Example: A Hypothetical Branded Drug:

Let us consider a hypothetical branded drug called "MedicaX," intended to treat chronic pain.

1. Preclinical Research: Laboratory studies on MedicaX showed promising results in reducing pain in animal models.

2. Phase 1: MedicaX was tested on 50 healthy volunteers to determine the safest dose and observe any immediate side effects.

3. Phase 2: The drug was then tested on 200 patients with chronic pain to evaluate its efficacy and optimal dosage.

4. Phase 3: A larger trial involving 1,000 patients compared MedicaX to a standard pain treatment, confirming its effectiveness and monitoring for side effects.

5. Phase 4: After approval, MedicaX was monitored in the general population to ensure long-term safety and effectiveness, with healthcare providers reporting any adverse effects.

Through this rigorous process, MedicaX was established as a safe and effective treatment for chronic pain, benefiting patients worldwide.¹⁴

CONCLUSION:

In conclusion, as healthcare investment grows due to technological advancements and improved diagnostic capabilities, medication costs are expected to rise substantially. With the increasing prevalence of chronic conditions like high blood pressure and diabetes, managing these costs effectively becomes imperative. Generic drugs play a crucial role in this effort by offering affordable alternatives to branded medications. They are manufactured to be identical in therapeutic efficacy, quality, and safety once the original drug’s patent expires, benefiting from lower production and marketing costs.

While branded drugs, protected by patents, come with higher expenses due to exclusive manufacturing and marketing rights, generics provide a cost-effective solution without compromising quality. The use of both generic and brand names helps differentiate between these drug types, though generics adhere to the same rigorous standards as their branded counterparts. The pace at which generics can replace branded drugs depends on supportive public policies and market conditions that encourage their adoption.

Ultimately, generics are essential for controlling healthcare costs while ensuring that necessary treatments remain accessible. By promoting the use of generics through favorable policies and practices, we can better manage healthcare expenses and maintain high standards of medical care.

REFERENCES:

1. Garrison GM, Oberhelman S. Screening for Hypertension Annually Compared with Current Practice. Annals of Family Medicine. 2013; 11(2): 116-121.

2. Generic medicines and Branded medicines. Available at http://www.myvmc.com/treatments/generic medicines and branded medicines. Accessed 15 October 2014.

3. Generic Drugs, Available at http://www.who.int/trade/glossary/ story034/en/WHO. Accessed 15 October 2014.

4. King DR, Kanavos P. Encouraging the use of generic medicines: implications for transition economies. Croat Med J. 2002; 43(4): 462-9.

5. Guidance on INN, WHO Available at http://www.who. Int/medicines/services/inn/inn guidance/en/index.html. Accessed 15 October 2014.

6. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009; 43:1583–97.

7. Singal G, Nanda A, Kotwani A. A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India. Indian J Pharmacol. 2011; 43:131–6.

8. www.wikipedia.org/ Branded and Generic Drug

9. Campbell, Jonathan D., Belozeroff, Vasily, Whittington, Melane D., Rubin, Robert J., Raggi, Paolo, and Briggs, Andrew H. Prices for Common Cardiovascular Drugs in the US are not Consistently Aligned with Value. Health Affairs. 2018; 37(8): 1298–1305.

10. U.S. Food and Drug Administration (FDA). The Drug Development Process. 2022. Retrieved from [FDA Website] (https://www.fda.gov/patients/drug-development-process/step-3-clinical-research)

11. European Medicines Agency (EMA). (2021). Clinical trials in human medicines. Retrieved from [EMA Website] (https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines)

12. World Health Organization (WHO). (2021). Clinical trials. Retrieved from [WHO Website] (https://www.who.int/health-topics/clinical-trials#tab=tab_1)

13. National Institutes of Health (NIH). (2023). NIH Clinical Research Trials and You. Retrieved from [NIH Website] (https://www.nih.gov/health-information/nih-clinical-research-trials-you)

14. National Center for Biotechnology Information (NCBI). (2020). Clinical Trials Phases. Retrieved from [NCBI Website] (https://www.ncbi.nlm.nih.gov/books/NBK526019/)

Received on 12.08.2024 Revised on 31.08.2024

Accepted on 15.09.2024 Published on 18.12.2024

Available online on December 21, 2024

Asian J. Pharm. Tech. 2024; 14(4):407-411.

DOI: 10.52711/2231-5713.2024.00064

Aspect	Branded Drugs	Generic Drugs
Definition	Drugs marketed under a trademarked brand name.	Drugs with the same active ingredients as branded drugs but sold under their chemical name.
Development	Developed and patented by a specific company.	Created after the patent on the branded drug expires.
Approval Process	Requires extensive clinical trials and regulatory approval.	Requires proof of bioequivalence to the branded drug; no need for extensive clinical trials.
Patent	Protected by patents, typically for 20 years from filing.	No patent protection; marketed after patent expiry.
Cost	Generally, more expensive due to R&D and marketing costs.	Typically, less expensive; lower production costs and no marketing expenses.
Brand Name	Marketed under a unique, trademarked brand name.	Marketed under its chemical name or a non-branded name.
Formulation	Can be available in various formulations (e.g., extended-release).	Must match the branded drug's formulation and dosage form.
Marketing	Includes extensive advertising and promotion	Limited marketing; often relies on cost savings to attract customers.
Efficacy	Both branded and generic drugs must meet the same efficacy and safety standards.	Must demonstrate that it is bioequivalent to the branded drug, meaning it performs in the same way.
Examples	Lipitor (Atorvastatin), Prozac (Fluoxetine)	Atorvastatin, Fluoxetine (generic versions of Lipitor and Prozac)