The FDA has granted interchangeability designation to HADLIMA™

The FDA has granted interchangeability designation to HADLIMA™  (adalimumab-bwwd; Samsung Bioepis, Organon), a biosimilar to Humira (adalimumab; AbbVie), as a high- and low-concentration autoinjector and a high-concentration prefilled syringe.

HADLIMA (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab).


The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis.


What is interchangeability?

According to the FDA

  1. An interchangeable biosimilar is a biosimilar that meets the additional requirements outlined by the law, allowing the FDA to approve both biosimilar and interchangeable biosimilar medications.
  2. An interchangeable biosimilar product may be substituted for the original product without consulting the prescriber, much like generic drugs are routinely substituted for brand-name drugs. This practice is called pharmacy-level substitution and is subject to state pharmacy laws.
  3. Both biosimilars and interchangeable biosimilars are as safe and effective as the original biologic to which they were compared, and they can be used in its place. This allows health care professionals to prescribe either a biosimilar or an interchangeable biosimilar product instead of the original biologic.

In the US, several adalimumab biosimilars have received interchangeable status.


1. Simlandi (adalimumab-ryvk); developed jointly by Alvotech and Teva Pharmaceutical Industries

2. Abrilada (adalimumab-afzb); developed by Pfizer

3. Cyltezo (adalimumab-adbm); developed by Boehringer Ingelheim

4. Yuflyma (adalimumab-aaty); developed by Celltrion, Inc.

5. Hadlima (adalimumab-bwwd); developed by Samsung Bioepis


The price indications for some of the above products from GlobalData are as follows.






Comments

Post a Comment

Popular posts from this blog

Gland Pharma is expected to secure 180-day exclusivity for Angiotensin II Acetate.

Image
This week, Gland Pharma received approval from the US FDA for the Angiotensin II Acetate Injection 2.5 mg/mL. Gland Pharma's Angiotensin II Acetate Injection is a generic version of La Jolla Pharma's Giapreza. Giapreza's sales are approximately $58 million in the U.S. market for the twelve months ending March 2025. Angiotensin II (ATII) is a naturally occurring peptide hormone that produces endocrine, autocrine, paracrine, and intracrine hormonal effects. It is a potent direct vasoconstrictor that narrows both arteries and veins, subsequently raising blood pressure. Its half-life in circulation is approximately 30 seconds; however, in tissue, it may extend to 15-30 minutes. ATII increases the secretion of ADH and ACTH and may enhance sympathetic effects through direct actions on postganglionic sympathetic fibres. Additionally, it acts on the adrenal cortex, prompting the release of aldosterone. Several patents are listed in OB by La Jolla Pharma’s Giapreza product.  Product...
Read more

Medical Reimbursement System in the US, J-Code, and the Potential Impact on 505(b)(2) Applications with Recent Changes

US Medical Reimbursment System The medical reimbursement system in the United States is very complex. I am not aware of any such system existing at the national level in India, so I cannot draw any parallels. In India, health insurance is primarily for hospitalisations, and, based on my information (which is mainly based on my health insurance), other reimbursements are generally not covered. However, I could be wrong. In the United States, there is HCPCS. Healthcare Common Procedure Coding System (HCPCS).  HCPCS is a standardised coding system used mainly for billing and processing health insurance claims, especially for Medicare and Medicaid.  The Centers for Medicare & Medicaid Services (CMS) maintains it. HCPCS is divided into two levels: Level I, which uses Current Procedural Terminology (CPT) codes, and Level II, which provides codes for products, supplies, and services not included in CPT.  You will notice that in the United States, almost everything is covered...
Read more