1b) We're launching with an important topic for #physicians #nurses #nursepractitioners #physicianassociates #pharmacists who provide care for individuals with #IBD: the use of #biosimilars. This program was also presented at the 2023 @amcporg annual meeting. pic.twitter.com/k9ICtfOkBp
— ibd_ce (@ibd_ce) April 20, 2023
2) This educational program is intended for healthcare providers and is supported by an unrestricted educational grant from Pfizer. Statement of accreditation and faculty disclosures are at https://t.co/F4a7a8fObJ.
— ibd_ce (@ibd_ce) April 20, 2023
3b) #Biosimilars are NOT #generics. Understanding this starts w/ the differences between #biologics and #small_molecule drugs. Small molecules are the most common type of pharmacotherapies. They are small by atomic size (e.g. Aspirin, 21 atoms). pic.twitter.com/kJVpyFL0kF
— ibd_ce (@ibd_ce) April 20, 2023
3d) Biologics such as #vaccines, #hormones (eg #epoetin alfa) & #monoclonal #antibodies (eg infliximab) are large (~103–104 atoms) and structurally complex, usually derived from living systems (e.g. cultured cells or organisms) . . . pic.twitter.com/GlN03ypxWB
— ibd_ce (@ibd_ce) April 20, 2023
3f) As such, the process of ‘replicating’ a reference small molecule product (to make a #generic) is much more straightforward and less expensive than the analogous process for a reference biologic (to make a #biosimilar). pic.twitter.com/38UDSHSCpe
— ibd_ce (@ibd_ce) April 20, 2023
5a) Unlike #generics, lot-to-lot variation can be 🔑 in evaluating #biosimilars. Per @US_FDA, biosimilar manufacturers must assess for variability between lots of the reference product and lots of the proposed biosimilar to ensure they are within an acceptable range. pic.twitter.com/F8kgXDCwny
— ibd_ce (@ibd_ce) April 20, 2023
6a) So unlike the reference product, a #biosimilar doesn't require a Phase 3 safety & efficacy clinical trial for approval, as this has already been demonstrated. Instead biosimilars must show a high degree of similarity to the reference product . . .
— ibd_ce (@ibd_ce) April 20, 2023
7) It's almost like the original #biologic approval process turned upside down! pic.twitter.com/sM7z1JJcu5
— ibd_ce (@ibd_ce) April 20, 2023
9) As more highly utilized biologics lose patent exclusivity, potential exists for more #biosimilars to become available over the next few years. As more are approved & prescribed, it is increasingly important for #HCPs to understand this terminology.https://t.co/d7C9KwwZLW pic.twitter.com/VqYVeJvIbO
— ibd_ce (@ibd_ce) April 20, 2023
11a) We have study data on #biosimilars, starting with #NOR_SWITCH study of biosimilar #infliximab, https://t.co/hQVV1B0lvO. pic.twitter.com/GxvLDBpDBr
— ibd_ce (@ibd_ce) April 20, 2023
11c) Patient characteristics are shown here: pic.twitter.com/uylgGdTKJp
— ibd_ce (@ibd_ce) April 20, 2023
12b) Frequency of #AEs was similar between groups:
👉#SAEs, 10% for reference vs 9% for CT-P13
👉overall #AEs, 70% v 68%
👉AEs➡️drug d/c, 4% v 3%— ibd_ce (@ibd_ce) April 20, 2023
13a) #SECURE study looked at the same #infliximab #biosimilar #CT_P13but specifically in adult pts w/ #UC or #CD in clinical #remission, on continuous treatment with reference infliximab for > 30wks.
🔓https://t.co/K1lKYDo4IB— ibd_ce (@ibd_ce) April 20, 2023
13c) In both groups, lower bound of 90% CI was > prespecified non-inferiority margin of 85%. Safety was similar. Authors concluded that switching to CT-P13 is safe & well-tolerated in pts w/ #IBD in remission. Similar results in 104wk f/u from Smits et al https://t.co/PsXopKwz4G. pic.twitter.com/VclgrXWXRk
— ibd_ce (@ibd_ce) April 20, 2023
14b) Phase 3 #RDB study in pts 18–80 w/ mod to severe #Crohn's, assigned 1:1 to #biosimilar or #adalimumabref product.
👉Primary endpoint was % w/ clinical response (#CDAI ⬇️≥70 points) at 4wk, non-inferiority margin 0·76— ibd_ce (@ibd_ce) April 20, 2023
14d) No significant difference in safety outcomes. Authors concluded that safety & efficacy were similar in pts w/ #Crohn's tx w/ #BI_695501 or #adalimumab reference product. Benefits were maintained in patients receiving adalimumab reference product who switched to BI 695501. pic.twitter.com/SdFUshJ6vu
— ibd_ce (@ibd_ce) April 20, 2023
15b) The patient receives a letter that his insurance is mandating a “switch to biosimilar”. The patient calls the office in a panic. He is feeling well and doesn’t understand why he must change medicines. pic.twitter.com/7TSujcHKRO
— ibd_ce (@ibd_ce) April 20, 2023
15d) .@CrohnsColitisFn reassures its stakeholders that
1⃣ #Biosimilarsare just as safe and effective as the original biologic tx ➡️no clinically meaningful differences.
2⃣ Biosimilars are taken in the same form (💊or 💉) & dose as reference product.— ibd_ce (@ibd_ce) April 20, 2023
16) Discuss with pt: A recent systematic review of 44 distinct studies of nonmedical (ie 💰) switching of reference #infliximab to an infliximab #biosimilar in pts with #IBD ➡️nonmedical switching in this population was safe with no efficacy, safety, or immunogenicity concerns.
— ibd_ce (@ibd_ce) April 20, 2023
18) Barriers to better implementation have been identified:https://t.co/rD2Zw2iTMW pic.twitter.com/M4QwIXao49
— ibd_ce (@ibd_ce) April 20, 2023
20) And in this #accredited program we are trying to address #HCP concerns, but these feed into patient concerns as well: pic.twitter.com/hCSGRNiCbw
— ibd_ce (@ibd_ce) April 20, 2023
22) The benefits to “the system” may be quite significant, as per the experience of our authors: pic.twitter.com/hrRn3UxZXC
— ibd_ce (@ibd_ce) April 20, 2023
24) It is essential that #HCPs familiarize themselves with data and policies, and use that knowledge to educate patients and maintain expected clinical outcomes at lower costs.
— ibd_ce (@ibd_ce) April 20, 2023
25b) It's d, totality of evidence. Biosimilars don't require Ph 3 trials, but there has to be clear similarity to reference product in such measures as purity, chemical identity, and bioactivity.
— ibd_ce (@ibd_ce) April 20, 2023
26b) It's d, all of the above . . . but you knew that, right?!? pic.twitter.com/cGNRAstmEj
— ibd_ce (@ibd_ce) April 20, 2023
27) And you just earned 0.75hr 🆓CE/#CME! Claim your certificate at https://t.co/talFCEJUek and FOLLOW US for more education in the #IBD space. Expert authors, always free, wholly on Twitter. @GI_PharmD and @AmanRheumPharm thank you for joining us!
— ibd_ce (@ibd_ce) April 20, 2023
