Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference product to biologics'possessing similar therapeutic properties. This year Apr 2020 has brought up approvals and launch of biosimilars like Biocon and Mylan launched, Fulphila (biosimilar, Pegfilgrastim) in Australia and Canada. Additionally, Merck also launched its biosimilar Ontruzant (biosimilar, trastuzumab) in the US. Sanofi has received CHMP's positive opinion targeted to treat patients with T1D/ T2D. Our team at PharmaShots has summarized 9 key events of the biosimilar space of April 2020.

1. Pfizer's Ruxience (biosimilar, rituximab) Received EC's Approval for Cancer Indications and Autoimmune Diseases

Date: Apr 02, 2020

Product: Ruxience (biosimilar, rituximab)

• The EC's approval was based on the REFLECTIONS B3281006 study assessing efficacy, safety, and immunogenicity, PK/PD of Ruxience that demonstrated the bio-similarity of Ruxience of its reference product, MabThera (rituximab)
• The approval followed the CHMP's positive opinion received in Jan'2020. The therapy is made available to the adult patients with NHL, CLL, GPA, and MPA in the US along with its launch in Japan in Jan'2020
• Ruxience is a mAb, biosimilar to the MabThera act by targeting CD20, present on the surface of B lymphocytes when it attaches to CD20, rituximab aid in destroying B cell  

2. Xbrane Biopharma Reported Update on the Ongoing P-III Xplore Study of Xlucane (biosimilar, ranibizumab)

Date: Apr 02, 2020

Product: Xlucane (biosimilar, ranibizumab)

• Xlucane is still on track towards regulatory approval ahead of Lucentis patent expiration in EU July 2022. Despite the COVID-19, Xplore continued the recruitment of new patients and treatment for patients currently in the study
• Xbrane ensured the safety of participants in the P-III study as well as the integrity of study data during the COVID-19 by following EMA's and FDA's recommendations. The company has currently recruited ~60% of the planned 580 patients
• Xbrane has agreed with the EMA and the FDA to submit MAA/ BLA, based on the interim read-out when the last patient has reached month six in the treatment schedule. Xplore is expected to record its last patient by the end Q3'20

3. Sanofi's Insulin Aspart Biosimilar Received CHMP's Positive Recommendation for Approval in the EU

Date: Apr 02, 2020

Product: Insulin Aspart Biosimilar 

• The CHMP's positive recommendation was based on the clinical development program that comprises P-I PK/PD study that evaluated product's similarity in exposure and activity1 and P-III Gemelli 12 study to evaluate the safety & efficacy
• The clinical program involves 600+ patients with T1D or T2D. Both the studies compared the biosimilar to insulin aspart 100 Units/mL as currently approved for use by adults with T1D/ T2D in the US and EU
• The CHMP's positive opinion marks the first regulatory milestone in the EU for any biosimilar insulin aspart product. Additionally, Sanofi has two rapid-acting insulin analogs approved in the EU

4. Biocon and Mylan Launched Fulphila (biosimilar, pegfilgrastim) in Australia

Date: Apr 14, 2020

Product: Fulphila (biosimilar, pegfilgrastim)

• The companies launched Fulphila, a biosimilar referencing Neulasta (pegfilgrastim) in Australia. The biosimilar received TGA's approval to treat cancer patients following the CT, to decrease the duration of neutropenia and to reduce the incidence of infections, as manifested by febrile neutropenia
• The approval was based on analytical, clinical, and nonclinical data which demonstrated that the Fulphila showed bio-similarity to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist
• Fulphila is the first biosimilar pegfilgrastim to be approved in the US and was successfully launched in Jul 2018 and has received regulatory approval in 30+ countries across the globe. The therapy is the third biosimilar to be commercialized in Australia and is available on PBS

5. Merck Launched Ontruzant (biosimilar, trastuzumab) in the US

Date: Apr 15, 2020

Product: Ontruzant (biosimilar, trastuzumab)

• Merck reported the launch of Ontruzant (trastuzumab'dttb), a biosimilar referencing Herceptin and will be available in both 150mg single-dose vials at a WAC of ~$1,325 and 420mg multiple-dose vials at a WAC of ~ $3,709, representing a 15% discount to the current list price of Herceptin
• The biosimilar is being launched as a part of a development and commercialization agreement with Samsung Bioepis, under which Merck has right to commercialize the therapy in licensed territories, including the US while Samsung Bioepis is responsible for pre/clinical development, manufacturing, CTs and regulatory registration
• Ontruzant showed high bio-similarity to Herceptin in terms of safety, purity, and potency of therapy and received the FDA's approval in Jan'2019. Merck will support the commercialization of Ontruzant until the spinoff, which expected to take place in H1'21

6. Biocon and Mylan Launched Fulphila (biosimilar, pegfilgrastim) in Canada

Date: Apr 28, 2020

Product: Avastin (bevacizumab)

• The companies have launched Fulphila, a biosimilar referencing Neulasta (pegfilgrastim) and is approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs
• The approval was based on analytical, non/clinical data, which showed that Fulphila is highly like Neulasta with no clinically meaningful differences in terms of safety and efficacy
• The launch will expand biosimilar access to the patients in Canada, following the successful launch of Fulphila in the US. This is the second biosimilar to be launched in Canada under Mylan and Biocon collaboration   

7. Richter Signed an Asset Purchase Agreement with Mycenax for Biosimilar Tocilizumab to Treat Rheumatoid Arthritis

Date: Apr 29, 2020

Product: Biosimilar Tocilizumab

• Mycenax received $5M upfront and $16.5M as the total deal value in four installments. Richter to get exclusive WW rights to develop, manufacture and commercialize Biosimilar tocilizumab
• The focus of the agreement was to bolster its rheumatology portfolio with the addition of Mycenax's candidate. The biosimilar tocilizumab assets comprise the cell lines, intellectual property (IP) rights, technology know-how also the data generated by Mycenax
• Tocilizumab is an investigational product formulated as subcutaneous and intravenous formulations targeted for RA with expected  commercialization in EU, Canada, Australia and Japan in 2025 and is approved for pediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome

8. Henlius HLX02 (Trastuzumab for Injection) Received EU GMP Certificates

Date: Apr 23, 2020

Product: HLX02 (Trastuzumab for Injection)

• Henlius has received two EU GMP certificate for drug substance (DS) line and drug product (DP) line for HLX02 (trastuzumab biosimilar) and has become the first EU certified site to self-develop an Ab drug depicting the company has a commercial-scale manufacturing facility and quality management as per EU standards
• The EU GMP inspection is recognized by nearly 30 EU the Member States also the inspection results may be shared with other countries signed MRAs with the EU including the US and Canada
• HLX02 (biosimilar, trastuzumab) is a biosimilar that has passed the EU GMP inspection in China, targeted for HER2+ve early-stage BC , HER2+ve mBC and HER2+ve mGC and showed no clinically meaningful differences terms of efficacy and safety in patients with recurrent or metastatic HER2+ breast cancer vs originator trastuzumab, also under review by the EMA for MAA. Additionally, has been evaluated in P-III trial vs originator in Mainland China, Ukraine, Poland, and the Philippines

9. Henlius Received NMPA's IND Approval for its HLX13 (biosimilar, ipilimumab)

Date: Apr 23, 2020

Product: HLX13 (biosimilar, ipilimumab)

• The approval followed the trials which involve assessing of HLX13 vs originator ipilimumab to evaluate its pharmacology, pharmacokinetics and toxicokinetics profiles, immunogenicity, and toxicity
• The study resulted in bio-similarity data in terms of in vivo and in vitro pharmacology, PK, toxicokinetics, immunogenicity and toxicity characteristics
• HLX13 is a recombinant anti-CTLA-4 fully human mAb injection resulting in  T cell activation in anti-tumor immune response and is developed under Chinese Biosimilar Guidelines approved for unresectable or metastatic melanoma, advanced RCC, MSI-H or dMMR Mcc and adjuvant treatment of melanoma

Related News: Insights+ Key Biosimilars Events of March 2020