Qual a diferença entre referência, genérico e similar?

Summary

This video explains the differences between reference, generic, and similar medications in the pharmaceutical industry. It covers how new drugs are developed and tested, including the importance of patents and the role of regulatory bodies like ANVISA. The script discusses how generics are cost-effective alternatives to branded drugs, offering the same therapeutic benefits without the high cost. It also clears up misconceptions about similar medications and provides guidance on when it is appropriate to substitute one medication for another. Overall, it aims to help viewers understand the complexities of drug pricing and options in Brazil.

Takeaways

• 😀 The pharmaceutical industry invests in research and development to create new medications, such as the innovative drug for 'blue finger disease' (degasolina).
• 😀 New drugs must undergo extensive testing, including in-vitro, animal, and human trials, to ensure they are effective, safe, and innovative.
• 😀 A drug is considered innovative when it introduces a unique element that differentiates it from existing treatments on the market.
• 😀 Once proven effective and safe, the new drug can be patented, granting exclusive rights to the developing company for typically 20 years.
• 😀 The patent process is lengthy and expensive, often taking over 10 years, and results in high prices for consumers due to the recovery of development costs.
• 😀 Once a patent expires, other companies can create generic versions of the drug, which are typically cheaper since they do not require the same research and development investment.
• 😀 Generic drugs are identical to their reference counterparts in terms of active ingredients, dosage, and effectiveness, but they are less expensive due to lower marketing and research costs.
• 😀 Unlike generics, similar drugs have the same active ingredient and dosage but may have differences in appearance, packaging, and inactive ingredients.
• 😀 Since 2003, similar drugs are required to prove their bioequivalence and safety, ensuring they are as effective as the reference drug.
• 😀 There is a misconception that a drug becomes a reference simply by being popular or heavily marketed, but this is not the case. A reference drug is always the original innovative product.

Q & A

What is the difference between a reference, generic, and similar drug?

A reference drug is an innovative medication that is originally developed and patented, usually with a new active ingredient. A generic drug is an identical copy of the reference drug in terms of active ingredients, dosage, and administration, but it is cheaper due to no development costs. A similar drug has the same active ingredient, dosage, and therapeutic indications as the reference drug but may have some differences in packaging, inactive ingredients, or shelf life.

Why does the pharmaceutical industry invest heavily in research and development?

Pharmaceutical companies invest in research and development to create new medications that address unmet medical needs. This involves extensive testing to ensure the drug is effective, safe, and innovative. The investment also helps to secure patents for exclusive rights to manufacture and sell the drug.

What is the purpose of a patent in the pharmaceutical industry?

A patent protects a new drug by granting the developing company exclusive rights to produce and sell the drug for a specific period, typically 20 years. This helps the company recover the costs of research, testing, and development while incentivizing innovation.

What are the benefits of generic drugs?

Generic drugs are more affordable because they don't incur the high costs associated with research and development. They offer the same therapeutic benefits as the reference drug but at a significantly lower price, making them accessible to a wider population.

How does the bioequivalence of a generic drug to its reference drug ensure safety?

Bioequivalence testing ensures that the generic drug is absorbed into the body in the same way as the reference drug. This proves that both drugs have the same therapeutic effect, meaning the treatment is just as safe and effective as the original.

What is the difference between a 'reference' drug and a 'similar' drug?

While a reference drug is an innovative, original product, a similar drug has the same active ingredients and therapeutic uses but may differ in some aspects like packaging, inactive ingredients, or shelf life. Similar drugs are not identical to reference drugs, but their efficacy and safety are equivalent.

Can a popular similar drug be considered a reference drug?

No, even if a similar drug becomes very popular, it does not become a reference drug. The reference drug is the original, innovative medication that all generics and similar drugs are based on. A drug can be popular, but that doesn't change its classification.

Why are generic drugs usually cheaper than reference drugs?

Generic drugs are cheaper because they do not require the significant investments in research, development, and marketing that reference drugs undergo. Manufacturers of generics only need to prove their equivalence to the reference drug and do not incur the initial costs of drug innovation.

What is the role of ANVISA in the regulation of medicines in Brazil?

ANVISA (National Health Surveillance Agency) is responsible for approving and regulating medicines in Brazil. It ensures that drugs meet safety, efficacy, and quality standards before they can be sold in the market. ANVISA also monitors patents and the approval of generics and similar drugs.

Why are there concerns about similar drugs, and how does ANVISA address them?

Concerns about similar drugs arise from potential differences in their composition or efficacy. However, since 2003, ANVISA has required all similar drugs to prove they are bioequivalent to the reference drug. This ensures their treatment is as effective and safe, and ANVISA maintains a list to help guide medical professionals and consumers.