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2024
On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab). These contracts effectively secure more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market.
On 9 February 2024, Biocon Biologics (Biocon) announced that it has signed a five-year exclusive partnership agreement with Sandoz AG. The agreement provides Sandoz AG the right to promote, sell and distribute Biocon’s OGIVRI® (trastuzumab biosimilar) and ABEVMY® (bevacizumab biosimilar) in Australia.
This comes months after Biocon announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan.
AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.
On 18 October 2023, the European Commission approved Enhertu® to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
The Hindu reported that Aurobindo Pharma subsidiary CuraTeQ Biologics has received a recommendation for marketing authorisation for its trastuzumab (biosimilar to Genentech’s Herceptin®) from India’s Subject Experts Committee of the Central Drugs Standard Control Organization (CDSCO).
In relation to another molecule (ustekinumab), CuraTeq Biologics entered into an exclusive commercialisation agreement with BioFactura in July 2023.
2023
New Zealand’s Pharmac has listed Celltrion’s Herzuma®, biosimilar to Genentech’s Herceptin®, on the Pharmaceutical Schedule for the treatment of breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology). Patients taking Herceptin® will need to move to Herzuma® by 1 June 2024 as Herceptin® will be delisted from the Schedule.
Chugai Pharmaceutical announced the Japanese launch of Phesgo®, a subcutaneous combination of pertuzumab and trastuzumab (Genentech’s Perjeta® and Herceptin® respectively) to treat HER2-positive breast cancer and advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.
The Japanese National Health Insurance (NHI) reimbursement price list included Phesgo® on the day Chugai launched it. Phesgo® was approved by the Ministry of Health, Labour and Welfare on 25 September 2023.
CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.
CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars). There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.
CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®. CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon Biologics’ Ogivri®.
EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers. On 30 April 2019, Sandoz and EirGenix inked a deal under which EirGenix develops & makes Herwenda®, and Sandoz commercialises the biosimilar on approval for all regions other than Taiwan, China, Russia, and some Asian countries.
On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Herwenda®.
An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar. Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.
On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®), to treat metastatic and early breast cancer and metastatic gastric cancer.
On the same day, Novartis’s shareholders approved the Sandoz spin-off which is scheduled for 4 October 2023.
According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement. PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:
New listing applications: | Amendment Applications |
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® | 1. Sanofi-Aventis’ Libtayo® (cemiplimab) |
2. GSK’s Jemperli® (dostarlimab) | 2. BMS’s Opdivo® (nivolumab) |
3. Vertex’s Kalydeco® (ivacaftor) | 3. Merck’s Keytruda® (pembrolizumab) |
4. GSK’s Menveo® (meningococcal vaccine) | 4. AbbVie’s Skyrizi® (risankizumab) |
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) | 5. Novartis’ Cosentyx® (secukinumab) |
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo® | |
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo® | |
8. Beigene’s Tevimbra® (tiselizumab) | |
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin® |
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.
On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).
Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved in Japan for a new indication: to treat unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.
On 12 July 2023, Enhertu® was approved in the US for a new indication (unresectable or metastatic HER2-low breast cancer).
Aurobindo Pharma announced that CuraTeQ Biologics’ BP02 showed equivalence to Genentech’s Herceptin® in its phase III clinical trial. The study’s results indicated that BP02 has clinical response equivalence (pharmacokinetics and immunogenicity) and comparable safety profiles to the originator product.
On 26 June 2023, CuraTeQ Biologics withdrew its EMA MA applications for biosimilars ZEFYLTI® (filgrastim) and DYRUPEG® (pegfilgrastim) after receiving guidance from the EMA.
The Economic Times in India reported that Glenmark provided a drastic price drop in India for Trumab® (trastuzumab), biosimilar to Genentech’s Herceptin®. Glenmark reduced the cost of its 440mg vial from ₹54,000 down over 70% to ₹15,749 in a market supplying the medicine for between Rs 40,000 and Rs 50,000 per vial.
Organon has published its results for Q1 2023, demonstrating biosimilars revenue increased 18% and 20% ex-FX. The results indicate that this increase was primarily driven by Renflexis® (biosimilar to Janssen’s Remicade® infliximab-abda) which grew 34% ex-FX due to continued demand growth in the United States and Canada as well as Brenzys™ (biosimilar to Amgen’s Enbrel® etanercept) which grew 36% ex-FX as a result of timing of tenders in Brazil. The report confirms that the ongoing competitive pressures in Europe more than offset strong US growth in Ontruzant®(biosimilar to Genentech’s Herceptin® trastuzumab-dttb).
Organon only launched Ontruzant® and Aybintio® (biosimilar to Genentech’s Avastin® bevacizumab) in Canada in November 2022.
A Samsung Bioepis study published in JAMA Network Open has demonstrated that SB3, its proposed trastuzumab biosimilar is comparable to Genentech’s Herceptin®. In their analysis of RCT outcomes of SB3 and Herceptin®, long term cardiac safety and efficacy were comparable after six years.
In February 2022, Samsung Bioepis announced that Health Canada has approved its Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Accord BioPharma, the US speciality division of Intas, announced that the FDA has accepted its BLA for proposed trastuzumab biosimilar HLX02 for adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 was originally developed by Accord’s business partner Shanghai Henlius Biotech, Inc. In 2021, Henlius granted Accord the exclusive rights to develop and commercialise HLX02 in North America.
Separately, on 15 February 2023 Henlius announced the FDA acceptance of Henlius’ BLA for HLX02. It is unclear whether this is the same BLA as that which Accord has recently announced.
Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HER2 low unresectable or recurrent breast cancer after prior chemotherapy. The approval was granted based on results of Daiichi’s DESTINY-BREAST04 phase III trials. Enhertu® combines a biosimilar to Gententech’s Herceptin® (trastuzumab) with chemotherapy drug deruxteca.
In August 2022, the FDA provided accelerated approval of Enhertu® for metastatic non-small cell lung cancer where tumours have activating HER2 mutations.
Korean Biomed has reported that Celltrion has entered into a joint R&D contract with GeneMedicine, a Korean anticancer virus development company, to develop CT-P6, biosimilar to Genentech’s Herceptin® (trastuzumab), in system administration form. Celltrion will provide the raw material and GeneMedicine will apply its proprietary nanomaterial-based platform technology (that enables effective and tumor-targeted systemic administration of oncolytic viruses). The companies plan to develop platform technology with the goal of completing the non-clinical parts of the development by the end of 2023.
Organon published its results for Q4 and full year ended 31 December 2022, reporting a second consecutive year of double-digit revenue growth in biosimilars. Organon reported that this growth was primarily drive by double-digit growth from Renflexis® (biosimilar to Johnson & Johnson’s Remicade® infliximab), Ontruzant® (biosimilar to Roche’s Herceptin® trastuzumab), Hadlima® (biosimilar to AbbVie’s Humira® adalimumab) and Aybintio® (biosimilar to Roche’s Avastin bevacizumab).
Henlius announced that the FDA has accepted its BLA for HLX02 (trastuzumab, biosimilar to Roche’s Herceptin®). According to the release, this is the first Chinese biosimilar to be approved in both China and the EU and may be the first to be approved in the US.
Genentech and Tanvex BioPharma filed a joint notice of settlement in the District Court of the Southern District of California, notifying the court that they have reached an agreement-in-principle to resolve all pending claims in relation to their dispute over Tanvex’s BLA submission for a biosimilar trastuzumab. The parties stated that they expect the final executed Joint Stipulation of Dismissal of all claims will be filed within 30 days.
2022
Former Genentech scientist Xanthe Lam and her husband Allen Lam were each sentenced to six months imprisonment and fines of over $10,000 for their role in the Genentech/JHL Biotech trade secrets scandal. The Lams plead guilty to stealing confidential intellectual property relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab) and Avastin® (bevacizumab), passing the information onto JHL Biotech to aid in its biosimilar development.
Prestige Biopharma announced that it has submitted a request to the FDA for a pre-submission meeting to discuss the planned BLA for Tuznue® (biosimilar trastuzumab). Prestige announced that it plans to submit the BLA by the end of the year.
Korea Biomedical Review reported that Prestige Biopharma has voluntarily withdrawn its EMA application for the HD201 (Tuznue®, biosimilar trastuzumab). Prestige received a negative opinion from the CHMP in May 2022, with the CHMP taking the view that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing. Prestige reportedly was not able to establish equivalence in a requested re-examination by CHMP. Prestige has represented that following withdrawal, it will supplement its data and resubmit with EMA this year.
Biocon Biologics announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab. Biocon Biologics reported that the observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades. Reportedly, Biocon Biologics does not expect the observations to impact current supply.
Henlius Biotech announced that the TGA has approved Henlius’ trastuzumab biosimilar, which will be marketed in Australia by Cipla. The 150mg/vial product HANQUYOU has been sold as Zercepac™ in Europe and will be offered under trade names Tuzucip™ and Trastucip™ in Australia, covering all indications of the reference product.
Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to Celltrion’s YuflymaTM (biosimilar citrate-free adalimumab). Under the agreement, Hikma will gain exclusive commercialisation rights to YuflymaTM in all of its Middle East and North Africa (MENA) markets. Hikma has launched a number of Celltrion biosimilars: Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab), with the launch of Remsima® SC (subcutaneous infliximab) in progress.
Roche reported that eight-year data from its Ph III trials of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy in HER2-positive early breast cancer demonstrates continued benefit of the combination in comparison to trastuzumab and chemotherapy alone. Roche reported a 28% reduction in the risk of recurrence or death in patients with lymph node-positive disease, and a safety profile consistent with previous studies.
Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.
The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab biosimilars Tuznue® and Hervelous®. The CHMP stated that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing, and considered that ”the studies presented did not provide enough evidence to show that the commercially produced medicine will be biosimilar to the reference medicine”. Korea Biomedical Review reported that Singapore based, Kosdaq-listed Prestige Biopharma will appeal the decision.
Amgen released its Q1 2022 financial results, reporting a 6% increase in YoY revenues. Amgen reported a 12% increase in Prolia® (denosumab) sales, a 7% decrease in Enbrel® (etanercept) sales, a 2% increase in Amgevita™ (biosimilar adalimumab) sales and a 40% decrease in Kanjinti® (biosimilar trastuzumab) sales.
The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary. Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab. Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.
Prestige BioPharma announced that the manufacturing facility for Tuznue® (biosimilar trastuzumab) has received EUGMP certification. Tuznue® is under Marketing Authorisation Application review in the EU, Canada and South Korea.
South Africa’s Competition Commission filed a referral with the Competition Tribunal for prosecution of Roche for alleged excessive pricing of trastuzumab.
Samsung Bioepis announced that Health Canada has approved Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.
2021
Sandoz announced that it has submitted a BLA to the EMA for a proposed biosimilar trastuzumab.
Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.
Dr Reddy’s and Prestige BioPharma announced that they have entered into an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.
Samsung Bioepis announced that its Ontruzant® (biosimilar trastuzumab) demonstrated comparable long-term survival results with reference trastuzumab in five-year follow-up results.
Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.
Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally advanced HER2 positive breast cancer. Samsung Bioepis reported that five year survival rates were 93.1% in the biosimilar trastuzumab group compared with 86.7% in the reference medicine group.
Celltrion announced that Herzuma® (biosimilar trastuzumab) gained 51% of the market share in Japan in June.
A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar trastuzumab) and pertuzumab administered as an admixture in a single infusion bag is consistent with what is known for reference trastuzumab and pertuzumab.
Amgen released its Q2 2021 financial results, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).
Celltrion announced it has won a tender to supply the Brazilian market with Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab).
Prestige BioPharma announced that HD201 (proposed trastuzumab biosimilar) demonstrated an equivalent pharmacokinetic and safety profile to reference trastuzumab in a bridging study completed last year.
Zydus Cadila announced it has launched Ujvira (trastuzumab emtansine) in India. Ujvira is an antibody drug conjugate biosimilar and is available in 100mg and 160mg vials at a considerable discount to the reference product.
Prestige BioPharma announced it has entered into a memorandum of understanding with the Busan City Government for the establishment of a R&D centre in Busan, South Korea. Prestige announced that the 45,000 m2 centre will house 209 new R&D personnel for the next five years. Prestige also announced that it has completed Ph III trials of its proposed trastuzumab biosimilar, and an application is currently under EMA review.
Biocon reported its Q1 2021 financial results. Biocon reported its biosimilars revenues from its subsidiary Biocon Biologics increased 53% year-on-year. Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.
Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.
EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.
The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.
Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.
Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.
The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe.
2020
The Centre for Biosimilars reports a new study indicates dramatically increased usage of trastuzumab biosimilars in the US. The study presented at the San Antonio Breast Cancer Symposium indicated that biosimilar use increased based on payer policies that favored biosimilars.
Prestige BioPharma and Teva Israel announce they have entered into an exclusive partnership and supply agreement for Prestige’s Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.
Korea Biomedical Review reports Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Government.
The Centre for Biosimilars reports two new studies for HD201 (Prestige Biopharma’s proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology. The first study, TROIKA-I demonstrated that HD201 was safe and well tolerated with PK comparability to the originator. The second, TROIKA was designed to compare safety, PK and efficacy based on the total pathological complete response rate. The investigators reported that the studies demonstrated equivalence between the biosimilar and reference products.
Accord Healthcare launches Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.
Shanghai Henlius Biotech announces China’s NMPA has approved its trastuzumab biosimilar Zercepac®. Zercepac® is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
Samsung Bioepis launches Ontruzant® (biosimilar trastuzumab) in Brazil. Ontruzant® is indicated for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.
Celltrion gains WHO prequalification for its trastuzumab biosimilar Herzuma®. The prequalification status enables Celltrion to make a bid in global procurement by UN agencies, and is based on an evaluation of safety and efficacy.
Shanghai Henlius Biotech and Accord Healthcare jointly announce the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.
Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06.
Henlius Biotech announces it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).
Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.
Samsung Bioepis announces the results of a four year follow up study of Ontruzant® (trastuzumab) will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) at the end of this month. The study assessed the cardiac safety and surival outcome in a subgroup of patients from the Ph III study.
Biocon Biologics receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.
Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.
Merck and Samsung Bioepis launch Ontruzant® (trastuzumab) in the US. Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline based therapy.
Biocad announces it has received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.
Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).
Teva and Celltrion launch Herzuma® (trastuzumab) in the US. Herzuma® is indicated for the treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer.
The US Federal Court of Appeals for the Circuit Court affirms the lower court’s refusal to preliminary injunct Amgen for its sale of biosimilar trastuzumab. Trial is expected to begin on 20 April, 2020.
Pfizer announces biosimilar TmAb Trazimera® will launch in the US on 15 February at a 22% discount to Herceptin.
Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab, etanercept, trastuzumab and bevacizumab candidates in Taiwan and Hong Kong.
2019
AffaMed receives Chinese approval to commence Ph III trials of Samsung’s trastuzumab biosimilar SB3.
NeuClone announces results of Ph I trials of trastuzumab biosimilar, reporting the product successfully met primary and secondary endpoints.
Mylan and Biocon announced the launch of Ogivri® in the US. This FDA-approved product was co-developed by Biocon Biologics and Mylan.
Shanghai Henlius announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials.
Celltrion and Juno announce Australian co-marketing partnership agreement for Herzuma® (trastuzumab) and Truxima® (rituximab). Under the agreement, Celltrion will hold the marketing authorisation and will be responsible for distribution, and Juno will provide sales promotion and hospital contracting services.
Celltrion announces Canadian approval for its biosimilar trastuzumab, Herzuma®, for the treatment of HER-2 positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
JHL announces it will immediately cease development and clinical trials of a number of biosimilars including rituximab, trastuzumab and bevacizumab as part of a settlement deal with Genentech. This agreement settles the 2018 dispute between the two parties, in which it was alleged that JHL had illegally obtained trade secrets from Genentech relating to these products.
Celltrion announces Japanese approval for three-week cycle of Herzuma® for the treatment of breast cancer.
Mylan and Biocon announce the launch of Ogivri® in Australia. This is the first TmAb biosimilar to be listed on the PBS, following approval in December 2018.
Both Amgen and Celltrion’s biosimilar trastuzumab products, Kanjiti® and Herzuma® respectively, were considered by Australia’s PBAC committee for PBS listing and A flagging (substitution). This follows the May 2019 PBAC recommendations for PBS listing of Mylan and MSD’s biosimilar products.
US District Court refuses Genentech’s request for a temporary restraining order and preliminary injunction against Amgen following Amgen’s launch of biosimilar trastuzumab Kanjinti®. In a memorandum opinion the Court has called Genentech’s request ‘contrary to the spirit’ of the BPCIA, stating that Genentech had been given warning of the upcoming launch in May 2018.
Celltrion announces creation of a JV Co with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The new company Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.
Samsung and Genentech settle patent dispute, allowing for the sale of Samsung’s Ontruzant®.
Prestige announces agreements with Pharmapark and Mundipharma for the supply and commercialisation of Tuznue® . An agreement reached with Pharmapark allows for supply and commercialisation in Russia, while the agreement with Mundipharma grants an exclusive license and supply of the drug.
Henlius announces that EMA has accepted Henlius’ MAA for trastuzumab biosimilar HLX02. This is the first Chinese developed TmAb biosimilar to be accepted for review by the EMA.
Health Canada approves Ogivri® for the treatment of HER2-positive breast cancer and HER2-positive metastatic stomach cancer. The product is the first TmAb biosimilar to be approved in Canada and is expected to be launched in the current quarter.
Amgen receives Australian approval for biosimilar trastuzumab Kanjinti®, in 60mg, 150mg and 420mg dosages.
Pfizer announces FDA approval of biosimilar trastuzumab Trazimera® for the treatment of HER2 positive breast cancer and HER2 metastic gastric or gastroesophageal junction adenocarcinoma.
Samsung Bioepis partners with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.
Samsung Bioepis announces partnership with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.
FDA approves biosimilar trastuzumab for all eligible indications. This is Samsung Bioepis’ first oncology biosimilar to receive FDA approval.
Samsung Bioepis obtains AU approval for Ontruzant®, biosimilar trastuzumab, in Australia. This is the third biosimilar TmAb to be approved in AU, following Celltrion’s approval of Simabtra® in July 2018, and Mylan’s approval of Ogivri® in December 2018.
2018
Shanghai Henlius’ research team presented an update on its TmAb clinical program with Phase III trials underway in Poland, Ukraine, Phillippines and China.
Prestige announces licensing agreement with Cipla, granting Cipla exclusive rights to distribute and market Prestige’s TmAb biosimilar in emerging markets.
Biocon announces EU marketing authorisation for biosimilar trastuzumub, Ogivri®. Ogivri® is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastic gastric cancer.
FDA approves TmAb biosimilar for the treatment of HER2-positive breast cancer. Herzuma® is the second TmAb biosimilar to be approved in the US. Celltrion is currently defending the biosimilar against Genentech, and while Genentech and Pfizer have reached a settlement, Celltrion, Amgen and Samsung Bioepis remain in litigation.
Genentech and Pfizer voluntarily dismiss all claims in litigation commenced in November 2017, each covering their own legal costs. While no details have been published, the dismissal suggests a settlement has been reached.
Alphapharm receives TGA approval for its biosimilar TmAb in Australia (Ogivri®) in 2 dosage forms (150mg, and 440mg powder for injection), four months after Celltrion received approval for its TmAb biosimilar products on 17 July 2018.
Samsung Bioepis announces comparable efficacy and safety to reference Trastuzumab in one-year follow-up study published at the San Antonio Breast Cancer Symposium.
Mylan and Biocon announce the CHMP’s positive opinion recommending Ogivri® (biosimilar TmAb) for approval in EMA. Approval is expected before the end of the year.
Nippon Kayaku launches Celltrion’s trastuzumab biosimilar in Japan, but only for the treatment of gastric cancers.
Pfizer announces EMA approval of biosimilar trastuzumab, Trazimera® for the treatment of human epidermal growth factor (HER2+) breast cancer and HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma. This is Pfizer’s 4th biosimilar to receive EU approval.
Dr Reddy’s announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers.
Celltrion obtains approval for its biosimilar TmAb products in Australia (150mg products branded as Simabtra®, Herzuma®, and Hertuzu®). These are the first biosimilar TmAb products to be approved in AU.
Biocon receives EU CGMP certification for its facility in Bangalore, clearing the way for the approval of pegfilgrastim and trastuzumab biosimilars.
Prestige and Alvogen announce partnership to commercialise Prestige’s trastuzumab biosimilar, Hervelous®, in Central and Eastern Europe.
Celltrion resubmits application for marketing approval of trastuzumab biosimilar to the FDA. This follows CRLs from the FDA related to the February warning letter regarding Celltrion’s manufacturing facility in South Korea.
FDA provides CRL rejecting Amgen’s application for biosimilar trastuzumab ABP 980, filed August 2017. Amgen states “we do not expect this to impact our US launch plans.”
CHMP recommends granting a marketing authorisation to Pfizer for its biosimilar trastuzumab (Trazimera®) for the treatment of breast and gastric cancer.
Celltrion announces that it intends to refile its aBLA for CT-P6 (trastuzumab) in June 2018 with a view to obtaining approval in 2018.
Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi’s third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD’s launch in March 2018.
Pfizer announces that it has received a CRL from the FDA for its BLA for biosimilar trastuzumab. The FDA has highlighted the need for further technical information.
Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10). The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year. Celltrion promises that the BLAs will be resubmitted “relatively soon” and that approvals are expected “in 6 months after resubmission”. The rejections were received 9 months after the BLAs were filed, and less than 2 months following the EU approval of Celltrion’s trastuzumab.
EMA’s CHMP adopted a positive opinion for ABP 980, Amgen/Allergan’s trastuzumab biosimilar Kanjinti®, 12 months after they announced filing the EC application.
Mundi and Celltrion enter exclusive distribution and marketing agreement for biosimilar trastuzumab, Herzuma®, for 7 EU countries including UK, DE and IT.
Merck launches the first TmAb biosimilar in Europe by selling the product developed by Samsung Bioepis (SB3) as Ontruzant® in the UK.
EC approves Celltrion’s Herzuma® (biosimilar trastuzumab), 2 months after the positive opinion from the CHMP on 14 December, 2017. This is Celltrion’s third EU approval and the second EU biosimilar trastuzumab approved in 3 months.
Celltrion and Teva commence proceedings in District Court (Northern District of California) seeking DJ that 38 patents relating to trastuzumab are invalid, unenforceable and/or not-infringed. This follows Celltrion/Teva’s US ABLA filing for biosimilar trastuzumab in late July 2017, and subsequent patent dance, and will test the boundaries of the availability of “DJ-within ABLA”.
2017
FDA approves Mylan/Biocon trastuzumab biosimilar Ogivri® for all “on-label” indications. This is the first US approved trastuzumab biosimilar, and Mylan’s first US biosimilar approved.
Samsung Bioepis receives regulatory approval for EU’s first biosimilar trastuzumab, Ontruzant® (to be marketed by MSD) for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Roche sues Pfizer in District Court of Delaware, alleging infringement of 40 patents, the first US lawsuit involving trastuzumab.
Samsung Bioepis announces that Samfenet®, biosimilar trastuzumab is approved by MFDS (South Korea) for the treatment of metastatic breast cancer, early-stage breast cancer and metastatic gastric cancer.
Samsung Bioepis announces it has received positive CHMP opinion on Ontruzant®, biosimilar trastuzumab for early breast cancer, metastatic breast cancer and metastatic gastric cancer. This is the first biosimilar trastuzumab recommended for EU approval.
Pfizer announces positive findings in pivotal Phase III study for TmAb candidate PF-05280014 at ESMO 17.
Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.
FDA extends its decision deadline by 3 months on a s351(k) application for MYL-1401O, Mylan and Biocon’s trastuzumab (Herceptin) biosimilar. Final decision is now expected by 3 Dec 2017.
Samsung Bioepis has filed three petitions seeking joinder with Hospira’s IPR against key Genentech trastuzumab patents (IPR2017-01958 against 6,627,196 patent; IPR2017-01959 against 7,371,379, and IPR2017-01960 against 7,892,549). Hospira’s petitions against the same patents (IPR2017-00804, IPR2017-00805, and IPR2017-00737) were instituted by the Board.
Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).
PTAB instituted IPR on 3 of Hospira’s 5 IPR requests relating to trastuzumab. The Board instituted IPR of the following patents: 7,371,379 (IPR2017-00805), 6,627,196 (IPR2017-00804), and 7,892,549 (IPR2017-00737). IPR was denied against 7,892,549 (IPR2017-00739) and 7,846,441 (IPR2017-00731).
Mylan’s biosimilar trastuzumab goes before the FDA Oncology Drugs Advisory Committee in the afternoon session on 13 July 2017, and receives unanimous recommendation for approval by FDA OCAC.
Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.
Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.
Mylan announces global settlement with Genentech & Roche on TmAb with global licenses (excluding Japan, Brazil and Mexico).
2016
Teva and Celltrion announce exclusive marketing deal under which Teva will commercialise Celltrion’s biosimilar rituximab and trastuzumab products in the US and CA.
2011
Stada and Gedeon Richter announce collaboration deals to develop and sell biosimilars rituximab and trastuzumab.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
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