Understanding State Laws for Interchangeable Biosimilars
October 15, 202112:40 pm
An important development in the biopharmaceutical world, with significant ramifications for patients, is the progress being made on biosimilars. These are products with the same safety and efficacy as FDA-approved biologic medications, but potentially less costly for patients. Below, executives with Cardinal Health, a global manufacturer and distributor of healthcare products and a Healthcare Leadership Council member, discuss the laws governing the interchangeability of biologics and biosimilars and how pharmacists can provide the medication that best meets their patients’ needs.
Understanding State Laws for Interchangeable Biosimilars
by Sonia T. Oskouei, PharmD, BCMAS, DPLA, Vice President, Biosimilars, Cardinal Health and Jeff Baldetti, Director, Biosimilars, Cardinal Health
Earlier this year, the FDA approved Semglee (insulin glargine-yfgn), the first interchangeable biosimilar in the US. The approval represented a significant milestone since the development of the Biologics Price Competition and Innovation Act in 2009 for a few reasons: it is the first interchangeable biosimilar to be approved in the US, it’s the first official biosimilar for an insulin product, and it’s the first biosimilar that will primarily be dispensed in retail pharmacies. With the approval comes the significant opportunity to help expand access to high-quality, lower-cost treatment options for patients with diabetes.
What Are Interchangeable Biosimilars?
Biosimilars are biologic products that are highly similar to, and as safe and effective as, existing FDA-approved biologics. Interchangeability is a regulatory designation that is unique to the US and is achieved through the submission of additional data (which per FDA guidance, may be in the form of switching studies). Interchangeability designation does not denote clinical superiority, as all biosimilars- whether interchangeable or not- meet the FDA’s rigorous regulatory standards for approval.
Why is Interchangeability Important?
The most important aspect of interchangeability is the implication associated with the designation. Interchangeability designation ultimately allows “pharmacist-level substitution,” whereby a pharmacist can automatically substitute the branded biologic with the biosimilar (as done routinely with brand and generics), per state laws. Given these implications, the designation is likely to have the greatest impact on biosimilars dispensed by pharmacists in the retail/specialty pharmacy setting (e.g., products billed under the pharmacy benefit).
Biosimilars are developed with the promise of increasing access and lowering costs for biologic therapies, which represent the most expensive drug category in the world. Interchangeability designation can position pharmacists to further enhance patient accessibility to biologics at a lower cost through automatic substitution authority.
State Pharmacy Laws
Currently, all 50 states and the District of Columbia have laws pertaining to interchangeability; however, pharmacy laws and practices vary from state to state, including requirements related to provider notification/permission, patient communication, and documentation practices. In addition, some states require that interchangeable products can only be swapped if the cost is lower, which adds a need for pharmacists to understand the managed care landscape, including PBM/payer formularies and policies and their impact on patient out-of-pocket costs. With the launch of an interchangeable version of Semglee (insulin glargine-yfgn) expected later this year, plus more interchangeable biosimilars seeking approval, it is critical for pharmacists to understand state requirements and prepare to operationalize these new treatment options.
Resources for Pharmacists
To help pharmacists navigate individual state laws regarding interchangeability, Cardinal Health has created an interactive map that provides pharmacists with key information to help prepare for interchangeability so they’re able to appropriately educate and support their patients with treatment options. The map details how each state defines interchangeability, clarifies the requirements pharmacists must follow to substitute biosimilars, and defines what healthcare providers and pharmacists need to know about switching to a biosimilar.
61 Responses to “Understanding State Laws for Interchangeable Biosimilars”
January 28th, 2024 at 11:20 am
buy ventolin inhalator without prescription cheap ventolin inhalator purchase albuterol sale
January 29th, 2024 at 6:59 pm
tizanidine generic zanaflex oral buy zanaflex pills
January 31st, 2024 at 9:17 am
prednisone 40mg uk cost deltasone 20mg deltasone 5mg drug
February 2nd, 2024 at 1:12 am
isotretinoin medication accutane 10mg generic where to buy accutane without a prescription
February 3rd, 2024 at 5:11 am
ventolin inhalator medication order ventolin 2mg sale order ventolin
February 3rd, 2024 at 3:00 pm
order amoxil 500mg for sale oral amoxil 500mg oral amoxicillin 1000mg
February 4th, 2024 at 10:59 pm
augmentin canada amoxiclav sale augmentin usa
February 5th, 2024 at 8:51 am
buy zithromax online order azithromycin 250mg generic zithromax 500mg ca
February 6th, 2024 at 2:47 pm
buy synthroid online cheap order generic levoxyl levothroid canada
February 7th, 2024 at 12:12 am
order generic prednisolone cheap prednisolone generic cheap prednisolone without prescription
February 8th, 2024 at 7:37 am
clomid uk clomid order online order serophene online cheap
February 8th, 2024 at 4:33 pm
cost neurontin 100mg how to buy neurontin gabapentin sale
February 10th, 2024 at 6:57 am
buy furosemide online order furosemide order lasix generic
February 10th, 2024 at 2:29 pm
viagra for sale online sildenafil without a doctor’s prescription order sildenafil 50mg pills
February 11th, 2024 at 3:34 pm
За сколько Продать Coleman Выкуп
February 11th, 2024 at 9:52 pm
order doxycycline 200mg monodox buy online monodox cheap
February 12th, 2024 at 5:28 am
semaglutide 14 mg pill buy rybelsus 14mg online cheap semaglutide usa
February 13th, 2024 at 7:50 am
free blackjack blackjack games free slots online
February 13th, 2024 at 4:33 pm
order vardenafil 10mg online levitra 10mg canada purchase vardenafil
February 14th, 2024 at 2:50 pm
Cialis Vs Sildenafil
It is possible to fill a blank?
Cialis 5 mg prezzo tadalafil 5 mg prezzo cialis 5 mg prezzo
February 15th, 2024 at 10:31 pm
aristocort 10mg pill buy generic triamcinolone over the counter buy triamcinolone 10mg pills
February 16th, 2024 at 12:37 pm
cheap tadalafil 5mg real cialis cialis 40mg brand
February 17th, 2024 at 5:08 am
buy desloratadine 5mg sale desloratadine where to buy buy clarinex paypal
February 17th, 2024 at 8:43 pm
buy cenforce generic purchase cenforce without prescription cenforce 50mg for sale
February 18th, 2024 at 10:42 am
order loratadine 10mg online loratadine generic order loratadine pill
February 19th, 2024 at 4:34 am
aralen generic aralen 250mg for sale generic aralen
February 20th, 2024 at 1:52 am
buy priligy generic purchase cytotec misoprostol 200mcg without prescription
February 20th, 2024 at 9:43 am
Aviator Spribe казино бонус
This situation is familiar to me. Is ready to help.
Добро пожаловать в захватывающий мир авиаторов! Aviator – это увлекательная игра, которая позволит вам окунуться в атмосферу боевых действий на небе. Необычные графика и захватывающий сюжет сделают ваше путешествие по воздуху неповторимым.
Наслаждайтесь игрой в Aviator Spribe играть казино и становитесь победителем!
Aviator игра позволит вам почувствовать себя настоящим пилотом. Вам предстоит совершить невероятные маневры, выполнять сложные задания и сражаться с противниками. Улучшайте свой самолет, чтобы быть готовым к любым ситуациям и становиться настоящим мастером.
Основные особенности Aviator краш игры:
1. Реалистичная графика и физика – благодаря передовой графике и реалистичной физике вы почувствуете себя настоящим пилотом.
2. Разнообразные режимы игры и миссии – в Aviator краш игре вы сможете выбрать различные режимы игры, такие как гонки, симулятор полетов и захватывающие воздушные бои. Кроме того, каждая миссия будет предлагать свои собственные вызовы и задачи.
3. Улучшение и модернизация самолетов – в игре доступны различные модели самолетов, которые можно покупать и улучшать. Вы сможете устанавливать новое оборудование, улучшать двигательность и мощность своего самолета, а также выбирать различные варианты окраски и декорации.
Aviator краш игра – это возможность испытать себя в роли авиатора и преодолеть все сложности и опасности воздушного пространства. Почувствуйте настоящую свободу и адреналин в Aviator краш игре онлайн!
Играйте в «Авиатор» в онлайн-казино Pin-Up
Aviator краш игра онлайн предлагает увлекательную и захватывающую игровую атмосферу, где вы становитесь настоящим авиатором и сражаетесь с самыми опасными искусственными интеллектами.
В этой игре вы должны показать свое мастерство и смекалку, чтобы преодолеть сложности многочисленных локаций и уровней. Вам предстоит собирать бонусы, уклоняться от препятствий и сражаться с врагами, используя свои навыки пилотирования и стрельбы.
Каждый уровень игры Aviator краш имеет свою уникальную атмосферу и задачи. Будьте готовы к неожиданностям, так как вас ждут захватывающие повороты сюжета и сложные испытания. Найдите все пути к победе и станьте настоящим героем авиатором!
Авиатор игра является прекрасным способом провести время и испытать настоящий адреналиновый разряд. Готовы ли вы стать лучшим авиатором? Не упустите свой шанс и начните играть в Aviator краш прямо сейчас!
Aviator – играй, сражайся, побеждай!
Aviator Pin Up (Авиатор Пин Ап ) – игра на деньги онлайн Казахстан
Aviator игра предлагает увлекательное и захватывающее разнообразие врагов и уровней, которые не оставят равнодушными даже самых требовательных геймеров.
Враги в Aviator краш игре онлайн представлены в самых разных формах и размерах. Здесь вы встретите группы из маленьких и быстрых врагов, а также огромных боссов с мощным вооружением. Разнообразие врагов позволяет игрокам использовать разные тактики и стратегии для победы.
Кроме того, Aviator игра предлагает разнообразие уровней сложности. Выберите легкий уровень, чтобы насладиться игровым процессом, или вызовите себе настоящий вызов, выбрав экспертный уровень. Независимо от выбранного уровня сложности, вы получите максимум удовольствия от игры и окунетесь в захватывающий мир авиаторов.
Играйте в Aviator и наслаждайтесь разнообразием врагов и уровней, которые позволят вам почувствовать себя настоящим авиатором.
February 20th, 2024 at 1:05 pm
glucophage 500mg cost purchase metformin generic glycomet 1000mg sale
February 21st, 2024 at 9:47 am
orlistat 60mg cost order xenical 120mg online diltiazem online buy
February 22nd, 2024 at 5:10 am
atorvastatin 80mg cheap lipitor 40mg sale purchase atorvastatin sale
February 22nd, 2024 at 4:03 pm
order zovirax 400mg online buy acyclovir 400mg generic order zyloprim generic
February 23rd, 2024 at 4:49 am
amlodipine online order order amlodipine online cheap buy norvasc 5mg sale
February 24th, 2024 at 12:37 pm
how to get lisinopril without a prescription purchase zestril generic lisinopril 2.5mg tablet
February 24th, 2024 at 4:33 pm
buy rosuvastatin crestor 20mg pill ezetimibe generic
February 25th, 2024 at 9:36 pm
purchase prilosec order prilosec generic omeprazole 10mg pill
February 25th, 2024 at 10:57 pm
brand domperidone purchase tetracycline online cheap purchase sumycin for sale
February 26th, 2024 at 10:16 am
Just wish to say your article is as astounding. The clarity in your post is just nice and i could assume you’re an expert on this subject. Fine with your permission let me to grab your RSS feed to keep up to date with forthcoming post. Thanks a million and please keep up the enjoyable work.
bitcoin price usd live
February 27th, 2024 at 4:06 am
brand metoprolol 50mg buy lopressor 100mg for sale metoprolol price
February 27th, 2024 at 7:12 am
buy flexeril 15mg generic oral lioresal lioresal for sale online
February 28th, 2024 at 2:59 pm
order toradol sale purchase toradol pill order colchicine 0.5mg pills
February 28th, 2024 at 3:29 pm
buy atenolol 50mg without prescription tenormin 100mg drug order atenolol 100mg
March 1st, 2024 at 1:04 am
methylprednisolone oral how to buy methylprednisolone purchase depo-medrol
March 2nd, 2024 at 7:49 am
cheap inderal cost propranolol purchase plavix online
March 2nd, 2024 at 8:26 am
pay for assignment pay for research papers academia writers
March 3rd, 2024 at 11:22 am
methotrexate pills methotrexate 5mg without prescription warfarin brand
March 4th, 2024 at 5:08 am
meloxicam over the counter oral celebrex order celecoxib 200mg
March 4th, 2024 at 3:10 pm
buy generic metoclopramide 20mg losartan ca order hyzaar without prescription
March 5th, 2024 at 4:34 pm
tamsulosin generic cost celebrex celebrex 100mg canada
March 5th, 2024 at 6:24 pm
how to get esomeprazole without a prescription esomeprazole for sale online buy topamax online
March 8th, 2024 at 5:46 am
zofran online ondansetron 4mg oral order spironolactone 25mg pills
March 8th, 2024 at 10:59 pm
buy imitrex 25mg sale imitrex 25mg pill order levofloxacin 500mg sale
March 9th, 2024 at 8:53 pm
buy simvastatin sale buy simvastatin pills for sale valtrex 1000mg pills
March 10th, 2024 at 3:17 am
dutasteride brand avodart 0.5mg drug zantac cheap
March 11th, 2024 at 11:45 am
finasteride where to buy proscar 1mg pills buy fluconazole 200mg online
March 11th, 2024 at 8:29 pm
buy cheap generic acillin generic acillin amoxil tablet
March 13th, 2024 at 1:32 am
propecia without prescription purchase diflucan buy fluconazole 200mg for sale
March 14th, 2024 at 7:00 am
order ciprofloxacin 1000mg sale – cost cipro 1000mg order augmentin generic
March 14th, 2024 at 9:17 pm
cipro 1000mg over the counter – augmentin 625mg cheap order amoxiclav online
March 17th, 2024 at 2:50 am
cost flagyl – order zithromax 250mg pills buy azithromycin 250mg online
March 18th, 2024 at 6:17 am
ciprofloxacin drug – buy erythromycin 250mg generic order erythromycin 250mg generic
Leave a Reply