Importance of Bio Similar Attorneys
The Biologics Price Competition and Innovation Act (BPCIA), formed in 2010 as part of the Affordable Care Act, lead a new era for large-molecule therapeutics. It provided an short pathway for regulatory approval of biosimilar and interchangeable biologics, also it introduced a statutory framework for resolving patent disputes involving those products.
In order to understand the complexity of biosimilar market domain a well informed and experienced Bio similar attorney which offer best practices & offers clients both the subject matter expertise and the trial savvy hands-on experience to effectively operate, and prevail, in this new era.
A bio similar attorney in many ways is identical to Hatch Waxman which operates within the exacting statutory framework of the BPCIA. Working within that model requires a team with precise knowledge of process, a deep domain knowledge in science, and extensive litigation experience.
Now coming to the question will taking Biosimilars Save Me Money?
The short answer: maybe, but not yet. Here’s why:
Biologics is an expensive process to manufacture. They’re expensive for customers to buy. Even a single dose can range from $10,000 and up or way up that $10,000. Though your insurance policy likely covers most of that cost, but there’s still a big collision on our overall health care costs because these very effective drugs are very expensive.
Before the approval, health insurers will get this update loud and clear and have started paying patients to try the biosimilar variants of medications to make this more spreaded use in an effort to manage the costs. According to the Biologics Price Competition and Innovation Act enacted back in 2009 was a U.S. legislation introduced by Congress to set up a “fast-track” development and approval proceedings for biosimilars.
It was part of a larger set of legislation called the Patient Protection and Affordable Care Act (ACA) passed in 2010. Once the BPCIA became law, the FDA set up a multi-step process for drug manufacturers to follow and develop a biosimilar.
Because of the many analytical and human tests done in the past have shown that few biosimilars are highly identical to its reference product that are safe and equivalently effective for consumption. In the FDA’s policy there wasn’t any need for a new biosimilar to duplicate clinical trials in patients with every disease. By doing so, the development of a biosimilar could save time and money.
Biosimilars cost less than their reference drugs. However, patients in the U.S. have not seen direct cost savings yet.
Certain manufacturers of biosimilars have started to market these drugs at much lower costs than their reference products. For example, infliximab-dyyb (Inflectra®) was introduced at a price that was 19 percent lower than infliximab’s (Remicade®) list price. Then in 2020, infliximab-axxq (Avsola®) was introduced at a list price that was 57 percent lower than infliximab’s (Remicade®) list price. However, those lower list prices have not resulted in lower costs for customers because insurance companies and pharmacy benefit managers do not pass these savings.
Health insurance companies say the lower price biosimilars, which are not passed on to patients, help to keep the price of premiums in check.
According to a nonprofit that analyzes many programs and industries, published a report in 2017 that analyzed that, overall, biosimilars by 2026 would cut spending on biologics by $54 billion. The drawback of this system is that it is set up in such a way that none of these savings go directly to the producers. When the cost is low for manufacturing, testing & marketing biosimilars could result in savings for the healthcare system, which in turn will yield good results for the medical healthcare domain.
Being a patient, it is your right to get some relief from rising drug costs. According to the group of America’s Health Insurance Plans (AHIP), as more biosimilars are being approved and allows to enter the market, competition will increase and prices will surely come down.
The FDA is observing the momentum of how the cost savings for biosimilars (or other drugs) are regulated from their manufacturer into the market, and in the end by the consumer. There may be savings on some front from the corporate rebates or discounts that are not passed on to you at this time. Hopefully, it is soon going to change so that you will pay less.
The attorney will make sure that the patient, deserve relief from rising drug costs. As per the solicit group of America’s Health Insurance Plans (AHIP), as more and more biosimilars are approved and are launched in the market, a health competition will increase and prices will eventually come down.
Strengths of Experienced Bio Similar Attorney
- Up-to-date knowledge of biosimilars legislation
- IP litigators with numerous trial and appellate successes
- Extensive Hatch Waxman litigation experience
- Successful Post-Grant PTO practice on behalf of patent owners and petitioners
- Extensive experience in biologics patent prosecution
- Licensing and other transactional experience related to biologics
The bottom line is that it is the duty of your attorney to make sure that every drug produced which has been approved for your customers by the FDA meets the required standards within the FDA’s framework. This includes both biosimilars and biologics. Being a prescription drug, in the U.S., the FDA would keep an eye as they are manufactured.
In few years there will likely be more biosimilars coming onto the market. Some of which that are already approved, but caught up in lawsuits, should become easily available to patients at a lower market cost.
So if you’re using a biologic now, and consideration that producing a new biosimilar drug and you are curious about whether a biosimilar may be a lucrative option for you, here are some tips:
- Speak to your attorney. Find out if there is a biosimilar that is available, and if your attorney thinks it may be right for you then you should consider producing the same
- Find out if your insurance plan covers the biosimilar. If it doesn’t, then let your attorney notify you whenever your biosimilar is available.
- Ask your doctor and your pharmacist to explain how the biosimilar will work as part of your treatment plan. As your duty, it is completely fine for you to ask any question that you have about its safety, effectiveness, and cost.
Therefore, to stay on top of things it is important to take care of all your legal affair sure way to free yourself from unnecessary headaches. It is always a good idea to have a Biosimilar attorney close to you even if you do not have problems at the moment.
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