Three pharmacy trends that will define 2022

The pharmaceutical industry made more headlines in 2021 than any other year in recent memory. And 2022 should also be a monumental year. Here are three key themes that will define the year ahead.

Interchangeability of biosimilars

In 2021, the FDA approved the first two interchangeable biosimilars in the United States: Insulin Glargine (yfgn) for Lantus and Cyltezo for Humira. These will provide much-needed, lower-cost options for patients on insulin and those with inflammatory conditions. More importantly, it shows that it is possible to achieve interchangeable status for organic products.

Unlike generic drugs, the production of biologics cannot be replicated exactly every time. It’s almost like different vintages of wine. The same vines in the same vineyard produce a slightly different product in each vintage. Wine from a neighboring vineyard may be extremely similar, but not identical.

As a result, the FDA sets a much higher standard for interchangeability of biosimilars than for generic drugs. Although clinically identical, most biosimilars of a brand name drug that are not interchangeable require a provider to write a prescription specifically for the biosimilar. Interchangeability allows pharmacists to interchange the biosimilar as a generic (unless blocked to preserve the higher cost and discount, but that’s another article).

Obtaining interchangeability has taken Glargine and Cyltezo years, and the latter will not hit the market until mid-2023 or even later if it is blocked by the patent extension and paid disputes. In the meantime, we’ll likely see more interchangeability approvals from the FDA.

Hopefully, this trend will begin to mitigate rising health care costs. Although unlike older generics which often cost pennies over the brand name drug, biosimilars tend to see a price reduction of only 15-30% due to the high cost of production and obtaining the drug. ‘approval. Moreover, at least for now, only one or two companies have a biosimilar for a given drug, compared to dozens of generic manufacturers.

Covid-19 treatments

Pharmacies across the country were very busy administering Covid-19 vaccines in 2021. In 2022, we will see a whole new weapon in our arsenal against the pandemic: Covid-19 pills.

Pfizer’s Paxlovid, an oral SARS-CoV-2-3CL antiviral drug, was recently cleared by the FDA for emergency use to treat Covid-19 positive patients ages 12 and older with mild to moderate symptoms at risk of developing serious illness. It has been shown to be up to 89% effective in preventing hospitalization and mortality when started within three days of diagnosis.

Although Merck reduced the effectiveness rate of its drug Molnupiravir in preventing hospitalization and death of adult patients with mild or moderate symptoms from 50% to 30%, it also received authorization for use emergency in December. With more than 1,000 Covid-19 deaths per day in the United States, having a second option as these treatments develop will make a big difference.

No side effects have been identified in either drug, but the potential long-term effects of Molnupiravir’s mechanism – which essentially introduces problems in the DNA replication of the virus – need to be investigated.

Previously, Covid treatments required intravenous administration. The convenience of these Covid-19 pills makes them somewhat comparable to Tamiflu, the flu treatment.

Additionally, adults and adolescents who are not recommended for Covid-19 vaccines, or for whom they would not be effective due to medical conditions or immunosuppressive medications, may be eligible for AstraZeneca’s Evusheld (tixagevimab co- packaged with cilgavimab; formerly AZD7442), a long-acting antibody combination for pre-exposure prophylaxis of Covid-19.

Just as it was hard to imagine life with freely available Covid vaccines in early 2021, new Covid treatments have the potential to change the pandemic landscape for the better in 2022. This is especially crucial given the lack of preparation and testing available as the omicron variant continues to ramp up.

Fast Track Quick Setting

The ups and downs of Aduhelm, the first Alzheimer’s treatment to emerge in many years, was a major story in 2021 that could mean a change of direction for acceleration in 2022 and beyond.

Accelerated approval is most common for oncology drugs and it’s easy to see the logic. If there is preliminary data that shows the drug is effective, why keep it out of reach of patients whose lives it could save?

As we progress through the accelerated trend, the downsides of this mentality begin to become apparent. Some post-marketing studies have shown that some accelerated oncology drugs do not improve or even worsen patient outcomes.

Also, because these are new niche drugs, fast-track drugs often come at a very high price. Families of patients going bankrupt for an ineffective drug is something no one wants to see; and it absolutely happens.

Cost and uncertainty played a major role in setting Aduhelm’s likely path to becoming a flop (although we won’t know for sure for some time). In any case, the FDA recently limited the drug to patients in clinical trials and will have to reckon with its entire fast-tracking process this year.

The extent to which the world depends on the pharmaceutical industry has certainly been demonstrated over the past two years. One thing all of these developments have in common – interchangeable biosimilars, Covid-19 pills and new thinking about acceleration – is that they are necessary for our industry to continue to improve and help as many people as possible.

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