When does humira become generic?

Humira, a game-changing medication for treating various autoimmune conditions such as rheumatoid arthritis and Crohn’s disease, is causing quite the stir in the pharmaceutical industry. While it has had incredible success in alleviating some pretty severe symptoms experienced by many patients worldwide, there’s one recurring question that keeps popping up – when does humira become generic?

Don’t worry; we’ve got you covered. In this article, we will explore everything you need to know about Humira generics with plenty of laughs along the way.

What on Earth Are Biosimilars?

Before getting down to brass tacks answering your golden question of “when does humira become generic,” we need to establish what biosimilars are first. Biosimilars are biological drugs that are almost identical copies of existing medications that have lost their patent protection in the market. In layman’s terms, think of them as knock-off versions.

In contrast to traditional chemical medications whose molecular structure can easily be replicated (hence why they became “generics”), these biologic medicines tend to be much trickier beasts because rather than being synthetic chemicals dug out from a lab somewhere, they contain living organisms or parts thereof which make them more complex and expensive!

So naturally speaking: Why would anyone want a copycat version rather than sticking with the original? Well…costs! It’s cheaper-producing knock-offs than creating fresh medicine from scratch, which also means savings passed onto consumers too; smart move right?

However, don’t get ahead of yourself just yet…

But Hold Up…

Biosimilars might sound like an excellent alternative/option for newly diagnosed patients looking for affordability instead of paying through their noses (ouch!), but sadly enough not everyone qualifies/can use them even if approved by regulatory authorities.

Furthermore though simply considering cost-cutting, you want to be sure you’re not compromising on the actual product’s quality and efficiency, right? I mean who wouldn’t? Only Nelly & Kelly could compromise; in real life – choice of medicine is a pretty serious matter.

Why Can’t We Get Humira Generics Right This Moment?

Humira continues to hold its reign over the usage demand worldwide. Yes, despite Humira’s active ingredient coming off patent in December 2016 (over four years ago!), no licensed biosimilar has reached the US market yet!

Yaj Kukreja a former Gilead executive recalls how lengthy trials are needed before they can approve any biosimilar for medication like humira because it’s complex ending with “The fact remains that this is still biologics development.” It seems everyone knows what needs doing but hey! A little patience never hurt nobody…right?

Here comes some interesting science facts:

  • The protein structure of their molecules means small differences between them might have an immense impact on efficacy.
  • Regulatory agencies require supporting data demonstrating that even minor changes will not affect patient safety or effectiveness.
  • Biosimilars by nature cannot be identical, per se – quite different from traditional generics made up of chemical compounds whose structural integrity guarantees therapeutic equivalence once approved.

All these multiple considerations result in delay and confusion around when does humira become generic? Speaking of timelines though…

Timeline: When Does Humira Become Generic Exactly?

Here’s everything we know about when does humira become generic:
  1. Amgen partnered with AbbVie, the original makers of humira aiming to develop a placeholder version as part of litigation settlement negotiations
  2. Fresenius Kabi submitted safe trials back in March concerning GP2017—their intended copycat version—yet hasn’t received FDA approval just at present!
  3. Mylan has been granted a license to sell Humira biosimilars across the EU since 2018 but results from their health economic studies have questioned how viable this has made them
  4. Sandoz, Momenta Pharmaceuticals and even Samsung Bioepis are all currently working on versions too!

These companies have sounded pretty upbeat regarding their attempts; so it shouldn’t be long (hopefully), before one of these submits positive reviews for regulators’ approval at some point.

What Does This Mean For You?

At this stage in your reading journey, whispers: you might think “Great! All is being done to get generic options soon”, however hold off celebrating just yet my friend!

Expecting humira generics can mean different things depending on where you live:

In Europe:
You’re most likely going to enjoy low-cost humira alternatives as and when Mylan or other biosimilar manufacturers finally obtain regulatory sanctions.

In the USA:
AbbVie seems committed not to follow the traditional route taken by loss-of-exclusivity drugs via launching smaller size dose pen models aimed at reducing patients’ expenses until they pass market exclusivity limits. This leads us back wondering – when does humira become generic?

In Australia:
You already have approved availability of Amjevita—an identical replica of AA rated therapeutic equivalence marketed by AbbVie themselves—for quite a while now according to TGA approvals!

Wait though…it’s Not That Simple

Sorry if we burst any bubbles concerning taking advantage of cost savings through Humira Generics anytime soon. However sad truth remaining that even when available, using alternative medicines should always involve prior medical consultation with your doctor.

Why? Primarily because interchangeability between products or class may cause issues concerning treatment indications furthermore start-ups from scratch could alter outcomes previously clinically tested for non-interchangeable products resulting in adverse reactions and worsening symptoms…(yikes!).

Final Remarks

While Humira generics currently seem like a far-off notion or science-fiction fantasy, don’t lose hope! Biosimilars are continuously becoming more of a reality in today’s day and age, so we should expect some viable alternatives soon enough!

Hopefully, you’ve enjoyed this article on when does humira become generic delivered with as much humor as possible; As always, consult your doctor before making medication changes.

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