Introduction to AVSOLA
AVSOLA (infliximab-axxq) is a biosimilar to Remicade (infliximab), an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. It was approved by the FDA in December 2019 for the same indications as Remicade, marking a significant milestone in Amgen's biosimilar and inflammation portfolios[2][4].
Clinical Trials and Efficacy
The approval of AVSOLA was based on a totality of evidence that included comparative analytical, nonclinical, and clinical data.
Comparative Clinical Study
A randomized, double-blind comparative clinical study was conducted to evaluate the efficacy and safety of AVSOLA compared to Remicade in patients with moderate to severe rheumatoid arthritis (RA). The study enrolled 558 patients who were randomized to receive either AVSOLA or Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22[1][2].
Key Findings
- The study demonstrated that AVSOLA was highly similar to Remicade with no clinically meaningful differences in efficacy and safety.
- Secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50, and ACR70 at various time points.
- A single transition study from Remicade to AVSOLA at week 22 showed similar safety and immunogenicity profiles[2][4].
Indications and Uses
AVSOLA is approved for several indications, mirroring those of Remicade:
Rheumatoid Arthritis
- Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA, in combination with methotrexate[2][4].
Crohn's Disease
- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.
- Similar indications apply to pediatric patients 6 years of age and older[2][4].
Ulcerative Colitis
- Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
- Similar indications for pediatric patients 6 years of age and older[2][4].
Plaque Psoriasis
- Treating adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate[2].
Psoriatic Arthritis
- Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis[2].
Ankylosing Spondylitis
- Reducing signs and symptoms in patients with active ankylosing spondylitis[2].
Safety Information
Patients treated with infliximab products, including AVSOLA, are at increased risk for developing serious infections that may lead to hospitalization or death. These infections are more common in patients taking concomitant immunosuppressants such as methotrexate or corticosteroids. Other common adverse reactions include infections, infusion-related reactions, headache, and abdominal pain[2].
Market Analysis and Projections
Global Biosimilars Market
The global biosimilars market is experiencing significant growth. In 2022, the market size was valued at $20.44 billion and is projected to grow to $73.03 billion by 2030, with a CAGR of 17.3% from 2023 to 2030[5].
Market Share and Key Players
Amgen, along with other major players like Novartis AG, Pfizer Inc., and Samsung Bioepis, holds a notable market share due to strong product offerings. The availability of biosimilars at lower costs compared to their biologic counterparts is a key driver of market growth, especially in regions with rising expenditure on chronic conditions[5].
Regional Growth
While Latin America and the Middle East & Africa are expected to grow at a slower rate, the overall trend indicates a robust expansion driven by the increasing demand for affordable biological treatment options. The approval and successful launch of biosimilars like AVSOLA contribute significantly to this market growth[5].
Impact on Healthcare and Patients
The introduction of AVSOLA and other biosimilars has the potential to significantly impact healthcare by providing more affordable treatment options for patients with chronic inflammatory conditions. Here are a few key points:
Cost Savings
Biosimilars like AVSOLA offer cost savings compared to their biologic counterparts, making these treatments more accessible to a wider patient population.
Treatment Accessibility
The approval of AVSOLA for multiple indications similar to Remicade expands the treatment options available to patients, particularly those who may not have responded adequately to conventional therapies.
Clinical Outcomes
The clinical trials have demonstrated that AVSOLA is highly similar to Remicade in terms of efficacy and safety, ensuring that patients receive effective treatment without compromising on safety.
Conclusion
AVSOLA represents a crucial addition to the biosimilar market, offering a highly similar alternative to Remicade with no clinically meaningful differences in safety and efficacy. As the global biosimilars market continues to grow, AVSOLA is poised to play a significant role in providing affordable and effective treatment options for patients with various chronic inflammatory conditions.
Key Takeaways
- Clinical Similarity: AVSOLA is highly similar to Remicade based on a totality of evidence, with no clinically meaningful differences in safety and efficacy.
- Indications: AVSOLA is approved for multiple indications, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
- Market Growth: The global biosimilars market is projected to grow significantly, driven by the demand for affordable biological treatment options.
- Cost Savings: AVSOLA offers cost savings compared to Remicade, making it a more accessible treatment option.
- Clinical Outcomes: Clinical trials have demonstrated similar efficacy and safety profiles between AVSOLA and Remicade.
FAQs
Q: What is AVSOLA and how is it related to Remicade?
A: AVSOLA (infliximab-axxq) is a biosimilar to Remicade (infliximab), an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. It has been approved for the same indications as Remicade.
Q: What were the key findings of the clinical trials for AVSOLA?
A: The clinical trials demonstrated that AVSOLA was highly similar to Remicade with no clinically meaningful differences in efficacy and safety. The primary endpoint of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22 was met.
Q: What are the approved indications for AVSOLA?
A: AVSOLA is approved for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, mirroring the indications of Remicade.
Q: How does AVSOLA impact the global biosimilars market?
A: AVSOLA contributes to the growth of the global biosimilars market by providing a more affordable treatment option, which is expected to drive market expansion, especially in regions with rising healthcare expenditures.
Q: What are the potential benefits of using AVSOLA over Remicade?
A: The primary benefit is cost savings, as AVSOLA is a more affordable alternative to Remicade without compromising on efficacy and safety.
Sources
- FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade (infliximab). Amgen Newsroom.
- FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade (infliximab). PR Newswire.
- AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS. Amgen Newsroom.
- AVSOLA®(infliximab-axxq)'s Totality of Evidence. AVSOLA.
- Biosimilars Market Size, Share, Trends | Global Report [2030]. Fortune Business Insights.
Last updated: 2025-01-19
