Insights+ Key Biosimilars Events of May 2019

Insights+ Key Biosimilars Events of May 2019

Biosimilars are going in market with vast emerging needs of people for multiple diseases. The biologics that are too costly to be used in the markets. Hence physicians are developing biosimilars “a reference product to biologics” which are biologically similar to biologics. Our team at PharmaShots have summarized some of the news regarding biosimilars in month of May 2019.

1.Fresenius Kabi Launches its Idacio (adalimumab, biosimilar) in Germany  

Date- May 4, 2019

Products- Idacio, adalimumab, biosimilar

The launch of Idacio is based on its MAA approval by EC for all indications of the reference product in therapy areas of rheumatology, dermatology and gastroenterology. The approval by EC follows EMA’s recommendation of product based on P-III study results assessing PK, safety, and immunogenicity with the reference product. Idacio is a mAb TNF inhibitor, targeted for autoimmune disorders, is available in pre-filled syringe, pre-filled pen and vial presentations. AbbVie and Fresenius Kabi collaborated to commercialize Idacio with its expected launch in September 2023.

2. The US FDA Issues Final Guidance on Interchangeable Biosimilars

Date- May 10, 2019

Products- Biosimilars

The US FDA finalizes its guidance on interchangeability of a biosimilar with its reference biologic, which means it may be substituted without prescriber intervening. The final guidance provides clarity to the developers that the proposed biological product should meet the interchangeability standard under the Public Health Service Act (PHS Act). Till date, the US FDA has licensed 19 Biosimilars as a part of Biosimilars Action Plan, targeted for patients’ access to lower-cost options. 

3. AbbVie Resolves Humira (adalimumab) Litigation with Boehringer Ingelheim

Date- May 14, 2019

Products- Humira, Adalimumab  

AbbVie has resolved the Humira litigation with BI, granting BI non-exclusive rights to BI for Humira’s IPR in the US. BI will pay royalties for licensing HUMIRA patents and acknowledges the validity and enforceability of the licensed patents. The initiation of the license will begin from Jul,1 2023.

4. NeuClone to Initiate P-I Clinical Study of Stelara (ustekinumab, biosimilar) in Australia

Date- May 15, 2019

Products- Stelara, Ustekinumab, Biosimilar

Neuclone plans for the onset of P-I clinical study for NeuLara, Stelara’s biosimilar evaluating NeuLara vs the US & EU score of Stelara in healthy candidates in Australia under CTN scheme of TGA in H2’19.    NeuLara is developed utilizing NeuMAX technology & Right from the Start development approach, analytically tested with X-ray crystallography for the confirmation of the identical structure b/w NeuLara and Stelara. J&J’s Stelara (ustekinumab) is a mAb targeting IL-12 and IL-23, approved for moderate to severe plaque psoriasis in adults and children aged ≥12yrs and has generated $5.2B revenue in 2018. NeuLara X-ray Crystallography is technique allowing 3-D imagining of complex molecules.

5. UnitedHealthcare to Use Brand-Name for Pegfilgrastim from July’19

Date- May 21, 2019

Products- Biosimilars

United healthcare will update its preferred product coverage criteria in its White Blood Cell Colony Stimulating Factors medical drug policy i.e, it prefers the use of Neulasta Onpro and Neulasta vial over Fulphila and Udenyca. Additionally, UH will expand its authorization requirements on these medications intended for any diagnosis. For both UnitedHealthcare commercial and Community Plan members, current authorizations will be honored through their end date. The policies will be updated after authorization renewal.

6. The US FDA Releases Draft Guidance Recommending on Comparative Analytical Assessment for Biosimilars

Date- May 21, 2019

Products- Biosimilars

The US FDA has released guidance on the design and evaluation of comparative analytical studies that are supporting demonstration of biosimilarity, with the withdrawn of previous draft guidance approach used to evaluate analytical similarity in June 2018. The new guidance includes improvement in analytical procedures with advancement in manufacturing science and production methods, for better targeting of the reference’s physiochemical and functional properties. FDA also encourages the use of state-of-the-art technology for analytical studies comprising part of a biosimilar’s application package with the submission of analytical data at IND stage as well.

7. Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval for HER2-Positive Breast and Gastric Cancers

Date- May 22, 2019

Products- Ogivri, Trastuzumab, Biosimilar

The approval is based on study assessing Ogivri vs Herceptin (trastuzumab) in patients evaluating its safety, efficacy, PK and immunogenicity. The study resulted with no clinical difference in safety, efficacy and potency between Ogivri and Herceptin. Ogivri (trastuzumab, biosimilar) is a mAb, currently approved in 65 countries including the US. Ogivri is one of the six biosimilar and second approved product co-developed by Biocon and Mylan. In Q2’19 Mylan plans to launch Ogivri in Canada.

8. Celltrion’s Herzuma (trastuzumab, biosimilar) Receives ANVISA’s Approval for Breast and Gastric Cancer in Brazil

Date- May 23, 2019

Products- Herzuma, Trastuzumab, Biosimilar

The Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria) has approved Herzuma (trastuzumab) in 150mg & 440mg for early-stage breast cancer, metastatic breast cancer and metastatic gastric cancer on May 20, 2019. Celltrion is also expecting ANVISA’s approval for Truxima, a biosimilar of Rituximab which helps in securing a leading market position in the Central-South American biosimilar market. Herzuma (trastuzumab-pkrb) is a biosimilar of Herceptin and has received FDA’s approval in Dec’18, also approved in EU (marketed by Mundipharma), in Japan (marketed by Daiichi Sankyo) and in Australia.

9. British Columbia Expands Use of Biosimilars to Explore Treatment Options

Date- May 27, 2019

Products- Biosimilar

BC decided to switch from reference product to biosimilars within 6 months, for patients suffering from diabetes, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. Post Nov 25,2019 PharmaCare, a publicly funded national drug coverage program will no longer be providing coverage for the biologic products with some exceptional cases and patients receiving Enbrel, Remicade and Lantus switch to Eticovo, Renflexis and Basaglar respectively. BC plan to save $96.6B in first three years and the decision is in practice with the listing of Jardiance and Taltz drug for diabetes and psoriatic arthritis respectively.

10. Prestige BioPharma Reports EMA’s Acceptance of Marketing Authorization Application for its Tuznue (trastuzumab, biosimilar)    

Date- May 29, 2019

Products- Tuznue, Trastuzumab, Biosimilar

Prestige Biopharma announces that EMA has accepted & validated MAA for its Tuznue, a biosimilar to Herceptin (trastuzumab) on May 23, 2019. Prestige’s Tuznue will be in competition with Celltrion’s Herzuma, Amgen’s Kanjinti, Merck Sharp & Dohme’s Ontruzant & Pfizer’s Trazimera in the European market, dominated by Roche’s Herceptin. Tuznue (HD201) is currently evaluated in P-I/P-III global studies and has received EMA’s CHMP positive opinion for marketing authorization. Additionally, Prestige has 8 biosimilar & biologics in its portfolio which are at different development stages.